Senior Manager, Regulatory Affairs CMC

Sarepta Therapeutics, Inc.; Cambridge (MA); On-site; USD 132,000 - 165,000; Full time

Job summary

An established industry player in genetic medicine is seeking a Regulatory Affairs professional to lead CMC development initiatives. In this pivotal role, you will collaborate with cross-functional teams to craft high-quality documentation and ensure compliance with regulatory standards. This innovative firm is at the forefront of developing therapies for Duchenne muscular dystrophy, providing a unique opportunity to contribute to life-changing advancements in medicine. If you are a solution-oriented thinker with a passion for regulatory affairs and a commitment to quality, this role offers a chance to make a significant impact in a supportive and dynamic environment.

Benefits

Comprehensive Benefits Package

Work-Life Resources

Physical and Emotional Wellness Support

Financial Wellness Support

Support for Caregivers

Qualifications

• 8+ years of relevant experience in regulatory affairs.
• Experience with IND/CTA, NDA submissions, and drug development.

Responsibilities

• Lead CMC regulatory strategies and submissions for projects.
• Ensure compliance with regulatory expectations and documentation.

Skills

Project Management

Regulatory Affairs Knowledge

Communication Skills

Analytical Skills

Knowledge of ICH Guidelines

Submission Content Understanding

Process Improvement

Education

Bachelor's Degree or Equivalent

Tools

Microsoft Office Applications

Regulatory/Quality Systems

Job description

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

1. Physical and Emotional Wellness
2. Financial Wellness
3. Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role
Take the lead or co-lead role in RA CMC development and/or marketed product initiatives, providing essential support for Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs. Collaborate closely with subject matter experts in CMC technical operations and QA, working within a dedicated CMC sub-team and serving as a key member of the GRT. Play a pivotal role in crafting high-quality, fit-for-purpose documentation (such as INDs, CTAs, NDAs, reports, and correspondences) to facilitate interactions with global Health Authorities.

The Opportunity to Make a Difference

1. Contributes to developing CMC regulatory strategies for assigned projects and programs while accurately interpreting and reflecting regulatory guidelines and corporate guidelines.
2. Coordinates the preparation and submission of documents to appropriate regulatory agencies for assigned projects and programs to implement regulatory strategy in line with corporate goals. Responsible for completing change control regulatory assessments, maintenance of regulatory tracker and submission preparation activities.
3. May lead CMC submissions and agency responses.
4. Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
5. Required to support preparation for inspection readiness.
6. Maintains/further develops knowledge of relevant evolving regulation and guidance.
7. Global Regulatory Teams - contributor to establish and implement regulatory strategy.
8. Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends.
9. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
10. Works on objectives that have major impact on functional area and the organization.
11. Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

More about You

1. BS or equivalent, 8+ years relevant experience.
2. Experience working in GRTs and cross functional teams.
3. Knowledge of drug development, ICH guidelines and regulatory process.
4. Experience of IND/CTA, IMPDs, Orphan drug designation, Agency Advice, NDA and/or MAA submission.
5. Demonstrated experience with and a clear understanding of submission content and format requirements.
6. Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders.
7. Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority.
8. Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details.
9. Ability to evaluate and recommend process improvement and suggest/implement best practices.
10. RAC certification recommended.
11. Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems.

What Now?
We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Remote

#LI-CM1

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.