Back to jobs

Senior Manager, Regulatory Sciences Compliance

Cambridge, MA

Overview

The Senior Manager, Regulatory Sciences Compliance (QSC) develops and maintains the compliance framework for in-scope Regulatory Sciences activities across Regulatory Strategy, Regulatory Operations, Labeling, Global Safety Operations, Medical Safety and Risk Management, and International functions. The role partners cross-functionally with process owners to translate regulatory obligations and operational risks into meaningful compliance indicators, governance, and sustainable improvement actions.

The role supports compliance throughout the product lifecycle from Good Clinical Practice (GCP) through Good Pharmacovigilance Practice (GVP), with emphasis on business-owned Regulatory Sciences processes, regulatory commitments, submission and reporting performance, and inspection readiness.

Activities governed by Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), including CMC regulatory compliance, manufacturing quality oversight, batch disposition, supplier quality, and GMP audit execution, are outside the scope of this role.

The role leads the design, implementation, and ongoing evaluation of Regulatory Sciences compliance KPIs and metrics, including determining which indicators are relevant, establishing consistent definitions and data sources, monitoring performance and trends, and partnering with accountable owners to define and track actions when thresholds or expectations are not met.

The position also provides compliance oversight and coordination for deviations and CAPAs, serves as a key business-side liaison with Quality Assurance, and drives proactive risk management, governance, and continuous improvement across the regulatory activities in scope.

This position is hybrid and will be primarily located in Cambridge, MA, USA.

 

Key Responsibilities

Compliance Oversight for Regulatory Sciences

  • Support and augment the QSC compliance framework as it applies to in-scope Regulatory Sciences activities, ensuring alignment with applicable regulatory requirements, commitments, internal procedures, and Quality Management System requirements.
  • Provide business-side compliance governance across relevant in-scope Regulatory Sciences subfunctions
  • Identify compliance risks and partner with Regulatory Sciences process owners and QSC leadership to prioritize, implement, and monitor proportionate mitigation actions.
  • Build effective cross-functional partnerships across Regulatory Sciences, Safety and Risk Management, Quality Assurance, data and technology teams, and adjacent GxP compliance functions to align expectations, resolve issues, and share relevant practices.

KPI Monitoring & Compliance Metrics

  • Partner with Regulatory Sciences stakeholders to identify and define relevant KPIs, key risk indicators, and compliance metrics that reflect regulatory obligations, operational performance, data quality, timeliness, and emerging risk.
  • Establish and maintain metric definitions, calculation logic, data sources, ownership, thresholds, reporting cadence, and escalation criteria to support consistent and reliable monitoring.
  • Develop and maintain compliance reports and dashboards that provide actionable insights for process owners and Regulatory Sciences leadership.
  • Assess metric performance and data quality, distinguish isolated events from recurring or systemic trends, and identify areas requiring further review, remediation, or escalation.
  • Partner with accountable process owners to define action plans, track completion, and evaluate whether actions have improved performance or reduced compliance risk.
  • Periodically evaluate the continued relevance and effectiveness of the metric portfolio and recommend additions, retirement, or refinement as processes, risks, and regulatory expectations evolve.

Deviation, CAPA, and Issue Management Support

  • Support oversight and management of deviations, CAPAs, and quality issues related to Regulatory Sciences activities
  • Facilitate root cause analysis, CAPA development, implementation tracking, and timely closure of quality events in partnership with accountable Regulatory Sciences process owners.

Quality Assurance Interface

  • Support internal audits and regulatory inspections impacting Regulatory Sciences activities.
  • Coordinate responses to audit observations and inspection findings related to Regulatory Sciences activities in collaboration accountable owners QA partners.
  • Ensure appropriate documentation and evidence are maintained to support inspection readiness.

Inspection Readiness Support

  • Support inspection readiness initiatives related to Regulatory Sciences activities
  • Conduct periodic readiness assessments and support remediation planning where gaps are identified.
  • Ensure documentation and records meet inspection expectations.

Governance & Process Improvement

  • Lead cross-functional continuous improvement initiatives informed by compliance data, recurring trends, process risk, and inspection or audit learnings to strengthen Regulatory Sciences operational compliance.
  • Facilitate governance discussions that convert metric and risk insights into clear decisions, accountable actions, target dates, and documented follow-through.

Qualifications

  • Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field and/or a licensed healthcare professional (advanced degree preferred)
  • Direct experience in Regulatory Sciences operations or compliance is required. A background focused primarily on GMP/CMC regulatory activities or traditional Quality Assurance activities, without experience in the in-scope Regulatory Sciences processes, will not align with the core needs of this role.
  • Minimum of 4 years of experience in the pharmaceutical or biotechnology industry, including substantial experience supporting Regulatory Affairs, Regulatory Operations, pharmacovigilance, or Regulatory Sciences compliance activities.
  • Strong knowledge of global regulatory frameworks, Regulatory Affairs and Regulatory Operations processes, pharmacovigilance interfaces, and Quality Management System expectations relevant to the activities in scope.
  • Demonstrated experience designing or improving regulatory-related KPI and compliance metric frameworks, including metric selection, definitions, data sourcing, thresholds, trend analysis, governance reporting, and action tracking.
  • Experience using data, dashboards, and trend analysis to identify compliance risk and drive measurable cross-functional improvement; experience supporting regulatory inspections and internal audits is strongly preferred.
  • Experience working within a Quality Management System environment and supporting cross-functional compliance governance from a Regulatory Sciences or business-process perspective.
  • Demonstrated ability to influence and partner with functional process owners, data owners, technology teams, and Quality Assurance while maintaining objective compliance oversight.
  • Strong facilitation, leadership, and project management skills, with the ability to align diverse stakeholders, clarify ownership, and convert complex compliance information into practical decisions and actions.
  • Excellent written and verbal communication skills, including the ability to communicate complex regulatory, risk, and performance information clearly to both technical and leadership audiences.
  • Ability to work independently, prioritize effectively, and operate successfully in a highly matrixed, cross-functional environment.
  • Proficiency with reporting and visualization tools and the ability to work with structured data are strongly preferred.

  #LI-AB1 #LI-Hybrid

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$135,400 - $183,200 USD

Create a Job Alert

Interested in building your career at Alnylam Pharmaceuticals? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...
Select...
Select...
Select...

*Note: Fixed Term Contractors please apply via the Internal Careers page

Select...
Select...

State Specific Applicant Notices

  • Arizona Applicants: To the extent required by applicable law, the Company maintains a smoke-free workplace.
  • Maryland Applicants:
    • UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
    • The Company considers this Application for Employment to be a part of the personnel record.
  • Massachusetts (MA) Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
  • Rhode Island (RI) Applicants: The Company is subject to Chapters 29-38 of Title 28 of the General Laws of Rhode Island, and is therefore covered by the state's workers' compensation law.
Select...

I understand the Company may obtain, without using the services of a third party investigative consumer reporting agency, public records pertaining to my character, general reputation, personal characteristics or mode of living during its evaluation of my application for employment and, if employed, during my employment.  

Select...

I acknowledge that I have read and understand the California Applicants Notice set forth above and confirm that I waive my right to receive copies of public records obtained by the Company under California Civil Code section 1786.53. 

Select...

Acknowledgement 

I have read and fully understand the questions asked in this application.  I certify that all of the answers I have given are true, accurate and complete.  I understand that the falsification, omission and/or misrepresentation of any fact from or on this application or during any interview will result in immediate rejection of my application or if I am hired will be cause for immediate dismissal.  I authorize the Company and its agents, including consumer reporting agencies, to independently inquire about, investigate and obtain copies of any records which relate to me from my former employers and educational institutions, and otherwise verify any of the information provided by me during the application process.  To the fullest extent allowable under applicable law, I hereby release the Company and all affiliated persons and entities, as well as any person or institution that provides the Company with any lawful information about me, from any and all liability whatsoever resulting from any such lawful independent inquiry, investigation or communication.

If hired, I understand that I will be required to abide by all of the rules and regulations of the Company.  I understand that nothing in this application shall constitute an offer, a contract or a guarantee of employment for a specific period of time.  If hired, I understand that my employment may be terminated with or without cause and with or without notice at any time, at the will of the Company or me, unless otherwise provided by applicable law.  I further understand that no representative or agent of the Company, other than the Chief Human Resources Officer has the authority to enter into any agreement for employment, on an individual or collective basis, for any specific period of time, or to make an agreement contrary to the foregoing.  I also understand that any agreement modifying at-will employment status, on an individual or collective basis, must be in writing and signed by the Chief Human Resources Officer.  In addition, I understand that the Company and all plan administrators shall have the maximum discretion permitted by law to administer, interpret, modify, discontinue, enhance or otherwise change all policies, procedures, benefits or other terms and conditions of employment.

US - Voluntary Self-Identification of Veteran Status

Invitation to Self Identify
EEO is the Law Poste

Why are you being asked to complete this form?

A "disabled veteran" is one of the following:

A veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or

A person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to.

Protected veterans may have additional rights under USERRA—the Uniformed Services Employment and Reemployment Rights Act. In particular, if you were absent from employment in order to perform service in the uniformed service, you may be entitled to be reemployed by your employer in the position you would have obtained with reasonable certainty if not for the absence due to service. For more information, call the U.S. Department of Labor's Veterans Employment and Training Service (VETS), toll-free, at 1-866-4-USA-DOL.

If you believe you belong to any of the categories of protected veterans listed above, please indicate by checking the appropriate box below. As a Government contractor subject to VEVRAA, we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information provided will be used only in ways that are not inconsistent with the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended

The information you submit will be kept confidential, except that (i) supervisors and managers may be informed regarding restrictions on the work or duties of disabled veterans, and regarding necessary accommodations; (ii) first aid and safety personnel may be informed, when and to the extent appropriate, if you have a condition that might require emergency treatment; and (iii) Government officials engaged in enforcing laws administered by the Office of Federal Contract Compliance Programs, or enforcing the Americans with Disabilities Act, may be informed.

Select...