Senior Director, Regulatory Strategy – Permanent – Massachusetts, New Jersey or Maryland
Proclinical is seeking a Senior Director, Regulatory Strategy for a global biotech company with locations in Massachusetts, New Jersey, and Maryland.
Primary Responsibilities:
In this role, you will be responsible for developing and executing regulatory plans for programs within the assigned franchise. As an expert within Regulatory, you will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. Prior regulatory experience with infectious disease & vaccine development preferred.
The position can be based at any of their US sites (Massachusetts, New Jersey or Maryland).
Skills & Requirements:
- BA/BS degree in a scientific/engineering discipline. Advanced degree preferred.
- 12+ years of experience in the pharmaceutical industry.
- 8+ years of experience in Regulatory strategy, including specifically: Vaccine Development.
- Experience with developing and implementing competitive regulatory strategies.
- Demonstrated track record in securing product approvals and maintaining a complex portfolio.
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU.
- Direct experience of leading regulatory authority meetings in different phases of drug development.
- Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.).
The Senior Director, Regulatory Strategy will:
- Serve as overall global regulatory lead accountable for all regulatory aspects of the COVID-19 franchise, including development and implementation of the global regulatory strategy and plans for programs within the franchise.
- Advises project teams regarding the development and implementation of regulatory strategy throughout each program’s life cycle.
- Ensures delivery of activities essential to maintain regulatory compliance and license to operate in countries worldwide where mRNA COVID-19 vaccines are authorized or licensed.
- Ensures alignment of regulatory activities with franchise priorities, alignment of regulatory risk mitigation plans across relevant sub-functions, and shared ownership of regulatory deliverables.
- Overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities.
- Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development and communicates potential impact to internal teams.
- Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.
- Establishes and maintains excellent relationships with global health agencies.
- Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
