How you’ll spend your day
The Manager, Regulatory Affairs will:
Prepare, review and approve regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance.
Prioritize many projects including early stage research and development, filing phase, deficiency rounds, and post-approval.
Assess risks throughout R&D, filing, deficiency rounds and post-approval and document these risks appropriately.
Escalate project issues and risks to management appropriately.
Lead preparation for meetings with FDA including defining questions and all supporting information for Pre-ANDA meeting with FDA for complex projects.
Lead deficiency response meetings: defining scope, deliverables, and response strategies.
Review and approve change notices, specifications, batch records, standard test methods, etc.
Implement policies to assure on-going compliance of Regulatory Affairs activities.
Assess impact of new regulations and suggest appropriate changes to business processes/policies as necessary.
Propose new efficiencies for Teva RA department’s day to day practices.
Interact with the FDA to facilitate approval of the regulatory submissions.
Maintain awareness of all regulatory activities on assigned projects.
Work to minimize regulatory issues and help prevent unnecessary regulatory delays.
Local telecommuting permitted up to 2 days per week. 5% domestic travel required.
Your experience and qualifications
REQUIREMENTS: Bachelor’s degree in Chemistry, Pharmacy, Pharmaceutics or a related field and 3 years of regulatory experience with a pharmaceutical company.
Must have experience with:
Regulatory filings such as NDAs, ANDAs, INDs, Amendments and Supplements;
Development of both complex and non-complex generics across a multitude of dosage forms including combination products;
FDA and ICH guidelines;
cGMP standards;
Federal and State laws related to pharmaceutical regulatory affairs;
Business, scientific and personal computer software applications including TrackWise harmony for change control; and
Using the FDA CDER NextGen Portal for submitting FDA communications.
Local telecommuting permitted up to 2 days per week. 5% domestic travel required.
