Manager/Senior Manager Regulatory Affairs

Work Schedule

Environmental Conditions

Job Description

Here’s What You’ll Do:

• Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.
• Coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, pediatric plans, DSURs, MAA/BLA/NDA, etc.
• Identify and assess regulatory risks for assigned projects or programs.
• Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate.
• Ability to work both independently and within project teams, committees, etc. to achieve group goals.
• Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies

Here’s What You’ll Bring to the Table:

• BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
• 5+ years of experience in the Pharmaceutical industry preferred in LATAM Countries.
• 3+ years of experience in Regulatory strategy or relevant training/experience preferred
• Experience in Infectious Diseases and/or Biologicals is preferred
• Strong knowledge of current US and EU regulations
• Strong experience with CTD format and content of regulatory filings
• Exceptional written and oral communication in English and Spanish.
• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
• Experience in authoring regulatory documents
• Knowledge and understanding of applicable regulations.
• Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.