Senior Director Regulatory Global Labeling
My client is a well-established biotech company focused on treating rare/orphan diseases for patients world-wide. They have been ranked as one of the top ten most innovative biotech companies and they are bringing new treatments to market that make a big impact on small patient populations. Their regulatory affairs team is expanding to accommodate their growling clinical pipeline and they are seeking a Senior Director (or Director) of Regulatory Global Labeling to lead the development of worldwide labeling and oversee the labeling team.
Responsibilities:
- Developing the strategy for labeling content for Target Product Profiles, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for use.
- Manage the strategic regulatory labeling health authority interactions labeling negotiations worldwide.
- Ensuring the execution of global regulatory labeling are aligned with the global regulatory strategy and corporate goals.
- Oversee and mentor labeling professionals to achieve regulatory objectives.
- Ensuring commercial product labeling is compliant with the worldwide regulations and company procedures.
- Present strategic global labeling issues to Regulatory Management and Executive Management on an ad-hoc/issue-driven basis for assigned projects/products.
- Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan.
- Lead US and EU labeling negotiations for the assigned products. Guide/ support REG International for all labeling related Health Authority negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
- Guide launch teams on launch strategy for new commercial products. Provide Supply Chain and QA guidance on labeling implementation requirements.
- Ensure all labeling documents are of the highest quality and represent the safe and effective use of the product.
Knowledge and Skills:
- A minimum of 10-12 years’ industry experience required and extensive experience (at least 4-6 years) in global labeling.
- Science based BS or MS degree with requisite experience and demonstrated capability. Advanced degree (MD, PhD, or PharmD) preferred.
- US and/or EU labeling expertise required and International and Core Labeling experience preferred.
- Experience leading teams and managing direct reports.
- Experience negotiating with internal and external stakeholders on complex regulatory issues.
- Thorough understanding of regulatory labeling requirements and strategic labeling planning.
- Outstanding interpersonal and communication (written and verbal) skills.
- History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- Biologics and rare disease experience is desirable.