Careers

At Opus Regulatory, we take pride in being a company who hires exceptional people who exemplify high standards and a passion to create significant benefits for our clients and employees. If you are interested in joining a fast-paced entrepreneurial team, where every person matters, submit your resume to humanresources@opusregulatory.com.  

 

Human Resource Manager

Founded in 1994, Opus Regulatory is an innovative consulting firm serving biopharmaceutical companies throughout the US.  Due to unprecedented growth, we are currently seeking an experienced and motivated Human Resource Manager for our company headquarters in Cambridge, MA.

This individual will be responsible for supporting HR administration, company benefits, compliance, HRIS, payroll, performance management and training, employee support, and recruitment. The ideal candidate is a self-starter who exemplifies high quality standards, is passionate about their work, and thrives in a fast-paced environment.

HR Administration:

  • New Employee Onboarding and Orientation
  • Maintain employee personnel files
  • Assist with HR projects as necessary
  • Oversee Payroll administration

Benefits Administration:

  • Monitors employee eligibility for benefits plans
  • Review benefits with employees and process enrollment, cancellation or changes.
  • Organize and manage annual enrollments, communications and election process
  • Maintain and distribute list of new and cancelled employees under each benefit plan.
  • Verify benefit billing accuracy and processes for payment
  • Administers COBRA for group health plans
  • Will assist with all leave management (FMLA, LTD, STD, etc.)

Compliance:

  • Ensures compliance with USCIS Form I-9 Employment Eligibility Verification
  • Maintain and processes all unemployment notices of entitlement and potential charges in a timely, efficient manner.
  • Attends unemployment hearings when necessary.

HRIS:

  • Own the HRIS function, maintaining and updating the system
  • Upload accurate and timely information
  • Conduct quarterly audits ensuring that all employee changes in the HRIS system are transferred to Payroll


Performance Management & Training:

  • Monitors, tracks and distributes tardiness, absenteeism and PTO reports
  • Manages and tracks all trainings and certifications
  • Provide and develop training for employees when needed

Employee Support/Relations:

  • Develop and implement new hire orientation
  • Fields employee questions.
  • Help develop and plan employee activities/parties
  • Maintain and coordinate employee recognition programs

Administrative and Ad Hoc Projects

  • Manage travel arrangements and expense reimbursements
  • Managing payroll tax registration, registered agent services and state openings/dissolutions

 
Recruiting:

  • Sourcing candidates leveraging social media platforms, employee referrals, and networking
  • Update candidate records via company CRM System to maintain current accurate information
  • Following up with paperwork
  • Developing and posting job descriptions on multiple portals and websites
  • Phone screening candidates, coordinating and conducting in-person interviews

Qualifications:

  • Bachelor’s Degree
  • 3-5 years of experience in Human Resource Management
  • Exceptional proficiency in MSOffice and a strong background in database/CRM systems and social media applications
  • Strong benefits administration experience
  • Must have strong compliance experience (FMLA, ADA, ACA, etc.)
  • Familiarity with HRIS systems
  • Working knowledge of payroll laws, payroll processing, state/federal taxes
  • Experience working in a startup/entrepreneurial culture, adaptable and willing to wear multiple hats
  • Personable Self-starter with the ability to collaborate with team members
  • Excellent organizational and multitasking skills with a detail orientation and a “no task is too big or small” attitude
  • Aptitude for learning industry technology with a genuine interest in the Pharmaceutical Industry

Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals. Our benefits program includes medical, dental and vision insurance in addition to 401(k) and paid time off.

For consideration, please submit cover letter and resume to humanresources@opusregulatory.com

PLEASE NO PHONE CALLS OR THIRD-PARTY RECRUITMENT AGENCIES

 

FTE and hourly Consulting opportunities exist for Senior Manager to Executive Director levels within all regulatory affairs functional areas including:

Most roles offer a significant home-based schedule.
Requirements: 4+ year's pharmaceutical regulatory affairs experience, advanced degree/science background preferred.

Consulting opportunities change frequently. For specific details, contact our HR department at humanresources@opusregulatory.com

 

Regulatory Affairs Principal Consultant – Advertising and Promotion

Role Summary

The Regulatory Affairs Principal Advertising and Promotion Consultant is primarily responsible for the daily support or management of regulatory requirements for one or more drug products, providing leadership on advertising and promotional materials, and developing and maintaining relationships with key client staff and regulatory bodies.

Responsibilities include:

  • Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
  • Provide strategic and operational leadership for promotional, educational, and investigative communications
  • Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy.
  • Manage launch preparation of promotional material for one or more products.
  • Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
  • Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
  • Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
  • Perform other duties as assigned.

Requirements and Competencies:

  • Position Types: Full or part-time; salary or hourly
  • Minimum experience: 6+ years pharmaceutical regulatory affairs experience
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)

Competencies

  • Expertise
    • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.
    • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
    • Regulatory submission knowledge, including eCTD and NDA/IND requirements.
    • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
  • Creativity
    • Ability to generate and employ original ideas to address simple and complex problems.
  • Resourcefulness
    • Ability to work in an ever-changing pharmaceutical environment.
  • Leadership
    • Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.
    • Ability to work collaboratively and direct the work of others toward common goals.
  • Adaptability
    • Ability to work in an ever-changing pharmaceutical environment and adapt to resource and knowledge gaps in client RA teams

Regulatory Affairs Principal Consultant – Labeling

Role Summary

The Regulatory Affairs Principal Labeling Consultant is primarily responsible for the daily support or management of regulatory requirements for one or more drug products, providing leadership on product labeling, and developing and maintaining relationships with key client staff and regulatory bodies.

Responsibilities include:

  • Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
  • Create and maintain primary and associated patient labeling, EU Product Information and labeling documents.
  • Ensure the quality and consistency of labeling documents, contributing to the continuous improvement of the client labeling process.
  • Lead or facilitate labeling approval meetings with relevant stakeholders (e.g., Regulatory, Legal, Marketing, Safety, Clinical) and advise teams on strategy, agency regulations, and guidance affecting labeling.
  • Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
  • Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
  • Perform other duties as assigned.

Requirements and Competencies:

  • Position Types: Full or part-time; salary or hourly
  • Minimum experience: 6+ years pharmaceutical regulatory affairs experience
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)

Competencies

  • Expertise
    • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.
    • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
    • Regulatory submission knowledge, including eCTD and NDA/IND requirements.
    • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
  • Creativity
    • Ability to generate and employ original ideas to address simple and complex problems.
  • Resourcefulness
    • Ability to work in an ever-changing pharmaceutical environment.
  • Leadership
    • Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.
    • Ability to work collaboratively and direct the work of others toward common goals.
  • Adaptability
    • Ability to work in an ever-changing pharmaceutical environment and adapt to resource and knowledge gaps in client RA teams

Regulatory Affairs Principal Consultant – Strategy

Role Summary

The Regulatory Affairs Principal Strategy Consultant is primarily responsible for the daily management of regulatory requirements for one or more drug products, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory bodies.

Responsibilities include:

  • Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
  • Create and maintain primary and associated patient labeling, EU Product Information and labeling documents.
  • Ensure the quality and consistency of labeling documents, contributing to the continuous improvement of the client labeling process.
  • Lead or facilitate labeling approval meetings with relevant stakeholders (e.g., Regulatory, Legal, Marketing, Safety, Clinical) and advise teams on strategy, agency regulations, and guidance affecting labeling.
  • Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
  • Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
  • Perform other duties as assigned.

Requirements and Competencies:

  • Position Types: Full or part-time; salary or hourly
  • Minimum experience: 6+ years pharmaceutical regulatory affairs experience
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)

Competencies

  • Expertise
    • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.
    • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
    • Regulatory submission knowledge, including eCTD and NDA/IND requirements.
    • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
  • Creativity
    • Ability to generate and employ original ideas to address simple and complex problems.
  • Resourcefulness
    • Ability to work in an ever-changing pharmaceutical environment.
  • Leadership
    • Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.
    • Ability to work collaboratively and direct the work of others toward common goals.
  • Adaptability
    • Ability to work in an ever-changing pharmaceutical environment and adapt to resource and knowledge gaps in client RA teams

 

Accounting Manager

We are looking for a reliable Accounting Manager who will be responsible for managing our accounting function and all areas of financial reporting. The position will develop and maintain accounting principles, best practices, and systems for collecting, analyzing, and reporting information. A strong understanding of Generally Accepted Accounting Principles (GAAP) is essential. The accounting manager will advise on budgets, financial strategy, financial reporting, and forecasting. The position will also be responsible for managing audit and ledger preparation, supporting the executive team, and possibly managing a team in the future.

Responsibilities include:

  • Plan, implement, and oversee the overall accounting strategy of the company
  • Own and complete the daily operations of the accounting function,
    including all bookkeeping:
    • Post financial transactions to accounting software
    • Invoice customers
    • Reconcile accounts
    • Maintain the chart of accounts and general ledger
    • Provide revenue and cash forecasting
  • Monitor and analyze accounting data to produce regular and ad hoc financial reports and statements
  • Oversee budget development, as well as budget analysis and reporting
  • Prepare financial KPIs for the leadership team
  • Support quarterly and annual tax preparation in conjunction with our CPA firm
  • Perform annual audits
  • Establish and enforce proper accounting principles, policies, and procedures that adhere to Generally Accepted Accounting Principles (GAAP)
  • Provide support for Opus timekeeping software, which includes liaising with clients and employees to ensure accuracy of time tracking
  • Support the HR function with a variety of tasks, including payroll

 

Required attributes: 

  • Four or more years of experience as an accounting manager, accounting supervisor, or finance manager
  • Advanced technical skills, including MS Office, QuickBooks Online, and other accounting software/databases
  • Ability to utilize and manipulate large datasets
  • Advanced knowledge of bookkeeping and accounting principles, standards, regulations, and laws
  • High attention to detail and commitment to accuracy
  • Strong interpersonal and written/verbal communication skills
  • Ability to multi-task in a high-paced, start-up environment
  • BA/BS degree in Accounting, Finance, or related field

 

Opus Regulatory, Inc. offers the benefits of both a dynamic entrepreneurial environment and financial stability.  We provide hands-on training, a competitive starting compensation plan, high income earning potential, and a comprehensive benefits plan (see below).  

Please respond with a resume and cover letter to:
humanresources@opusregulatory.com

 

Recruiter

We're looking for a seasoned Recruiter to join our team as we grow from 40 to 100+ employees across the US. As a member of the Talent Acquisition team, you will be responsible for sourcing world-class talent and guiding candidates through the entire interview process. If you're a team player with an eye for talent who loves connecting people and opportunities, this is the role for you.

 

Responsibilities include:

  • Act as a hiring partner for a world-class pharmaceutical consulting team
  • Collaborate with stakeholders to deeply understand hiring needs
  • Source qualified candidates, review resumes, and pre-screen candidates while moving the interview process forward in a timely manner
  • Provide consultative recruiting services including research and market intelligence
  • Organize and facilitate interview debriefs
  • Support candidate negotiations and the job acceptance process
  • Proactively provide candidates with the right information to facilitate their decision-making process
  • Interface regularly with internal stakeholders including the Director of Human Resources, Account Executives, and the CEO.
  • Maintain a continuous pipeline of candidates for urgent talent acquisition needs
  • Create and own a flawlessly positive candidate experience
  • Work for an organization that values talent acquisition as a pillar of success and a key component of its mission

 

Required attributes: 

  • Possess high-level communication skills
  • Prioritize a seamless candidate experience and serve the needs of the business and its leaders
  • Think critically and creatively, adapt easily to changing priorities, optimize time, and enjoy collaboration
  • Operate autonomously and proactively seek out solutions to problems
  • Are naturally curious, continuously learning and reflecting on their own growth
  • Possess a relentless drive to find and connect with the best talent; maintain a disciplined strategy to source, engage, and nurture prospective candidates
  • Passionately believe that great talent is the foundation for any company's growth and success
  • Have proven experience in building and managing a diverse candidate pipeline

 

Required background:

  • 3+ years of professional recruiting experience. Experience within the pharmaceutical industry preferred;
  • A bachelor’s Degree in Human Resources, Public Health, or a related field;
  • A combination of education and experience

 

Opus Regulatory, Inc. offers the benefits of both a dynamic entrepreneurial environment and financial stability.  We provide hands-on training, a competitive starting compensation plan, high income earning potential, and a comprehensive benefits plan (see below).  

Please respond with a resume and cover letter to:
humanresources@opusregulatory.com

Equal Employment Opportunity Policy

Opus is committed, in accordance with applicable law, to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants. It will not discriminate on the basis of race, color, religious creed, national origin, ancestry, sex, marital status, sexual orientation, age, disability, or as a disabled Veteran, or any other basis protected by law.
While Management is responsible for the development of plans, programs, and controls to ensure that our policy is carried out, we expect all employees to provide individual and collective support for equal employment Opportunity at Opus Regulatory.

Opus Regulatory will provide reasonable accommodations, in accordance with the regulations of the Americans with Disabilities Act, and State law.

 

Our Benefits

Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals. Our benefits program offers a broad array of plans to support our workforce physically, financially, and personally. We currently offer the following benefits:

Health & Wellness

  • Medical
  • Dental
  • Vision

Financial

  • 401k retirement plan
  • Life insurance
  • Short-term and long-term disability

Quality of Life

  • Paid vacation
  • Paid holidays
  • Paid Sick days
  • Paid personal days
  • Paid jury days
  • Most Regulatory Consultant positions offer significant home-based arrangements

This summary is an overview of benefits to prospective employees. More extensive information is provided to new employees upon hire.  Paid time off, paid holidays and paid personal days are offered to full time employees.

Current Opportunities

Regulatory Affairs Consultants

• Advertising / Promotion

• Labeling

• Regulatory Strategy

Recruiter