Director, Regulatory Affairs Strategy

Alternative Resources Company

Director, Regulatory Affairs Strategy

Director, Regulatory Affairs Strategy
  
Job Summary

This position leads the preparation, alignment and formulation of a global regulatory strategy with direct accountability for US and/or Europe across the product lifecycle for the Oncology portfolio. Primarily leads product support and maintenance for marketed products in company territories, but also may support programs in all phases of development. Act as a specialist for specific fields of regulatory or therapeutic knowledge. Represent RA globally and regionally in internal and external interactions (e.g. project teams, working teams, health authorities, affiliates, partners).
  
Responsibilities
  • Maintains a high level of regulatory knowledge across the product lifecycle and provides regulatory advice
  • Define and implement Local and/or Global RA strategy for assigned products in the company territories. Lead and coordinate all required life-cycle management and maintenance processes for assigned marketed products such as new submissions in late tier countries, re-submissions, variations and renewals including affiliate and partner management. Lead and manage divestment processes and due diligence to marketed products. Be responsible for response to issue management and queries from Health Authority agencies to satisfactory conclusions. Provides business advice, context and groundwork for scientific and commercial development.
  • Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor.
  • Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across the company to obtain and/or provide information/data for regulatory submissions.
  • Leads the formulation of registration strategies for products/projects. Ensures US and/or EU registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan and ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives.
  • Provides regulatory affairs representation on project teams; may lead regulatory sub-teams. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the project team.
  • Mentors and provides guidance to junior RA staff in a matrix environment.
  
Qualifications
  • Bachelor’s degree in Life Science or Medical Science, Pharmacy degree preferred; PhD or Master’s Degree a plus.
  • Minimum 10 years of experience in the pharmaceutical industry with 5-8 years of direct regulatory affairs experience with emphasis on Life-Cycle Management and Maintenance of US and ex-US licenses.
  • Proven experience in a strategic leading role and submissions experience in US and other ex-US markets. Support of Oncology products desirable.
  • Working knowledge of laws, regulations and guidelines is essential. Experience working in a global, international regulatory environment.
  • Understanding of drug development and regulatory processes. Ability to interact effectively with FDA and other agencies. Ability to provide technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects.