Senior Manager, Regulatory Project Management

Overview

The Senior Manager of Regulatory Project Management will report to the Sr. Director of Regulatory Technology and Operations. Given Alnylam’s uniquely robust pipeline, a need has been identified to establish a focused capability to develop and implement best practices for key regulatory submissions throughout the development product lifecycle including global expansions. This role will be accountable for supporting high-impact regulatory activities for key development milestones, and corporate goals.  This role will work closely with the Global and Regional Regulatory Leads, Regulatory Operations functions, as well as cross-functional filing teams and management, to facilitate timely submissions of high-quality data packages to US, EU and global health authorities. 

This position will be based in our Cambridge, MA or Philadelphia, PA location

Responsibilities

• Lead regulatory-focused project management activities across the R&D product lifecycle, including global expansion.
• Develop and continuously optimize detailed regulatory project plans and timelines in close collaboration with the Global Regulatory Lead, Regulatory Operations, and sub-team leads.
• Identify and manage project interdependencies to ensure alignment across functions and understand critical path activities.
• Maintain real-time filing timelines and track key submissions/deliverables from investigational and marketing applications to registration.
• Interface with filing sub-teams to ensure mutual understanding and agreement on submission timelines and deliverables.
• Plan and facilitate cross-functional meetings/workshops (e.g., filing kick-off) to drive execution of submission strategies.
• Facilitate and co-lead critical filing team and sub-team meetings, ensuring follow-through on project deliverables and action items across the relevant expertise areas (e.g., nonclinical, CMC, clinical, regulatory functions).
• Ensure development of document reviewer/approver matrices and coordinate review cycles and roundtables aligned with submission timelines.
• Maintain comprehensive project dashboard(s) to communicate progress, risks, and key updates to teams and senior management.
• Proactively identify and escalate risks related to resources, timing, and deliverables as appropriate.
• Coordinate lessons learned sessions and facilitate implementation of feedback for process improvement
• Contribute to the development and refinement of best practices and standardized processes for key regulatory submissions.

Qualifications

• Bachelor's degree in life sciences, pharmacy, or related field preferred with at least 6 years’ experience in regulatory affairs or project management within the pharmaceutical or biotech industry
• Demonstrated project management skills with strong ability to prioritize multiple projects.  Formal project management training is a plus.
• Proficiency in project management tools (e.g., Smartsheet, MS Project) and content management systems. Experience with timeline visual tools (OnePager, Think-Cell, Office Timeline, or similar) is a plus.
• Experience managing global regulatory submissions for initial investigational and/or marketing applications, including response to health authority questions.
• Understanding of regulatory processes, requirements and experience in interpretation of Health Authority guidelines.
• Ability to work both independently and collaboratively within a matrixed, cross-functional environment, leveraging strong interpersonal skills to build effective partnerships across departments and levels.
• Excellent written and verbal communication skills, including negotiation skills.
• Excellent organizational and meeting management/facilitation skills.
• Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion.
• Detail-oriented with a strong sense of accountability and urgency.

U.S. Pay Range

$128,900.00 - $174,300.00

The pay range 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

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.