Director, Regulatory Affairs Strategy

I am currently working with a key client of mine in NJ that are looking to hire a Director, Regulatory Affairs Strategy to their Oncology team. This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. This position acts as point of contact for interactions with Health Authorities (HA) and global cross-functional team members and may lead team(s) when conducting FDA and/or EMA interactions. This position fosters a global view on cross-functional teams, and mentors and provides guidance to junior RA representatives. This position provides regulatory advice on internal or partnered development assets. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, FDA Project Managers and/or Reviewers, and may interact directly or indirectly with ex-US Health Authorities

Responsibilities

1. Regulatory Knowledge: Maintains a high level of regulatory knowledge and provides regulatory advice.
2. Agency Interactions: 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.
3. Dossier Submissions: Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across my client to obtain and/or provide information/data for regulatory submissions.
4. Registration Strategy: 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.

Qualifications

• Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.) with preference for M.D. and Ph.D. JD with appropriate regulatory experience would be considered.
• Experience in the pharmaceutical industry (8-10 years), including direct oncology regulatory affairs with the FDA preferred.
• Experience with ex-US regulatory authorities would be a plus

If you would like to have the opportunity to discuss this role, please dont hesitate to reach out to the team directly, or submit your resume

Director, Regulatory Affairs Strategy