Position: Senior Director, Global Regulatory Affairs Strategist Job 2334
Location: NYC Metro Area
Compensation: Based Upon Experience
What you’ll do:
Reporting to the Head of Regulatory Affairs, you will guide the regulatory strategy for the Company’s research oncology initiatives and sponsor work. In addition, you will:
Develop, implement, and manage the global regulatory strategy consistent with overall company objectives, strategy, both as a business and in partnership with sponsors’ specific drug product/asset needs
Support business development due diligence activities as required
Ensure the Company’s adherence to all local and national regulatory reporting obligations and requirements in all relevant jurisdictions (including pharmacovigilance obligations), and support the processes and audit functions or interfaces to properly implement these responsibilities in partnership with Quality organization
While it is not anticipated that the Company will take primary responsibility for health authority submissions, critical components of regulatory submissions are expected deliverables from sponsors who work with us, and as such writing expertise among the regulatory affairs team is required.
Who You Are:
You're a regulatory science expert and leader with at least 8 years of experience in regulatory oncology drug development within the biopharmaceutical industry.
You have an advanced degree (e.g. PharmD, PhD, MD), however an extensively broad and deep set of experiences within the discipline of regulatory sciences within biopharma may be sufficient with a BA or BS or equivalent
You have been direct liaison with Health Authorities
You have cross-functional team experience and product team leadership experience
You have experience with IND/CTA through BLA/NDA/MAA or equivalent submission requirements, preferably with both the US FDA and EMA; the US FDA is a minimum
You have fluent knowledge of all stages of pharmaceutical drug development and compliance and documentation
You are knowledgeable in ICH, FDA and EMA statutes, guidances, initiatives, and other regulations governing regulatory compliance and reporting, including safety reporting and processing within the clinical investigation and post marketing settings
You have strong organizational, matrixed leadership, teamwork, and interpersonal skills, as well as a passion for developing teams
You have experience managing and developing a team
You have outstanding communication skills (written and verbal, both formal and informal)
You have the ability to manage multiple projects simultaneously in a fast-paced environment
You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams