Sr Manager, Regulatory CMC
Who We Are
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
- Proactively manage the planning, preparation and submission of Chemistry, Manufacturing & Controls (CMC) aspects of global clinical and/or marketing applications. Ensuring sections are complete, well-written, and meet all relevant requirements.
- Managing interactions with global regulatory authorities to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
- Evaluating proposed manufacturing changes for global impact, providing strategic regulatory guidance for optimal implementation of changes.
- Researching and interpreting global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development, and other functional groups within the Technical Operations organization.
- Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
- Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
- At least 5-7 years of experience in global Regulatory Affairs CMC or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle)
- Experience with leading clinical trial applications, marketing authorizations, post-marketing supplements for pharmaceutical or biologic products in the US and/or Europe is required.
- Thorough understanding of relevant drug development regulations and guidelines.
- Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.