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Senior Regulatory Manager - CMC

Job Advert

Want to steer the growth of a major global brand? As a Senior Regulatory Manager - CMC you’ll have the freedom to show us what’s possible and help drive innovation that makes an impact. Globally.

Senior Regulatory Manager - CMC
Parsippany, NJ
Competitive Salary & excellent benefits package

As the Senior Regulatory Manager CMC, you work autonomously to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility. You’ll succeed because you'll

  • Function as RA CMC lead for the Health business including drugs, devices and filings and experience in dealing with issues pertaining to the launch and support of new products.
  • Provide strategic RA CMC interpretation and guidance to project teams from early development through post-approval.
  • Determine the content and direct the development of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, INDs, etc.) and ensure these documents meet high scientific standards and regulatory requirements.
  • Interact with manufacturing and quality groups, regulatory agencies, partner organizations, regarding RA CMC issues
  • Provide technical leadership, coaching, mentoring and knowledge sharing for the RA CMC team.
  • Stays abreast of, interprets, and communicates existing and/or proposed government regulations, registration requirements to Operations, Business, and R&D disciplines and applies these changes as necessary to facilitate RB’s business plans and long-term goals.
  • Serve as the point of contact with FDA for CMC submissions, audits and investigations.
  • Establish and maintain communication channels and constructive rapport with key partners in Quality, R&D, Marketing and Supply Chain to streamline and maximize information and documentation flow.

You’ll love it because…
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Nearest Major Market: New York City
Nearest Secondary Market: Newark

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