Senior Manager, Regulatory Affairs CMC

Sarepta Therapeutics; City of Rochester (MA, NY); Hybrid; 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. This role offers the chance to work on groundbreaking therapies for muscular dystrophies, collaborating with cross-functional teams to ensure regulatory compliance. The ideal candidate will have extensive experience in drug development and a strong understanding of regulatory processes. Join a forward-thinking company that values integrity and innovation, and make a meaningful impact on patients' lives while enjoying a supportive work culture and competitive benefits.

Benefits

Comprehensive Benefits

Work-Life Resources

Support for Caregivers

Physical and Emotional Wellness Programs

Financial Wellness Programs

Qualifications

• 8+ years of experience in Regulatory Affairs with a focus on CMC.
• Knowledge of ICH guidelines and regulatory processes.

Responsibilities

• Lead CMC regulatory strategy and documentation for assigned projects.
• Coordinate submissions to regulatory agencies and maintain compliance.

Skills

Regulatory Affairs

Project Management

Cross-Functional Team Collaboration

Drug Development Knowledge

Submission Content and Format Requirements

Adaptive Communication Skills

Process Improvement

Education

Bachelor's Degree

Tools

Microsoft Office

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:

• Physical and Emotional Wellness

• Financial Wellness

• 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.
You may also oversee the activities of junior regulatory personnel, fostering their growth and development. Build and maintain strong relationships across global and cross-functional teams to ensure seamless communication and efficient implementation of regulatory activities for assigned programs. Continuously apply and expand your knowledge of market-specific regulatory procedures to drive success in your role.

The Opportunity to Make a Difference

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

More about You

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