Senior Regulatory Specialist

5 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time
International Regulatory Lead Job Description

We are seeking a highly skilled and experienced International Regulatory Lead to join our team. As an International Regulatory Lead, you will be responsible for advising global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.

  • Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
  • Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
  • Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within our portfolio.
  • Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
  • Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
  • Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
  • Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
  • Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
  • Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
  • Partners with peers to agree on product strategy including projected submission and approval time.
  • Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
  • Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
  • Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to our products.
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Required Skills and Qualifications
  • Bachelor's degree in a related field or equivalent experience.
  • 10+ years of relevant regulatory experience in a biotechnology industry.
  • Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes.
We Offer

As a valued member of our team, you will have the opportunity to work on challenging projects, collaborate with talented professionals, and contribute to the growth and success of our organization.

If you are a motivated and results-driven individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

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