Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
