Manager of Regulatory Affairs
Experienced CMC (Chemistry Manufacturing Controls) professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions, and compliance activities for development programs and commercial products supporting the Business Unit little to no supervision.
Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities.
Leads the initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks, and develops contingency/mitigation plans with little to no supervision.
Required Education and Experience:
- BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
- Must have a minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
- Must have a minimum of 4 years drug substance or drug product development or manufacturing technical support experience.
- Experience with diverse dosage forms, particularly sterile combination products, is desirable.
- The colleague will be an experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain. Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.
- The colleague will have a sound understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
- Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
- Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
- The colleague will have a clear track record of effective teamwork, collaboration, and communication, and demonstrated leadership ability in a cross-functional matrix team environment.
- Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.
- Chemistry Manufacturing Controls (CMC) Files CMC submissions.
- Health, Dental, and Vision Insurance
- 401k (and employer matching program)
- HAS / FSA
- Life, Disability, and AD&D Insurance
- Pet Insurance
- Employee Assistance & Wellness Support
- Tuition Reimbursement
- PTO and Holidays