Director, Global Regulatory Labeling – Permanent – Massachusetts, New Jersey or Maryland
Proclinical is seeking a Director, Global Regulatory Labeling 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 labeling, especially generation of new US prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies. This role will also be responsible for leading and supervising their consultants and service providers.
The position can be based at any of their US sites (Massachusetts, New Jersey or Maryland).
Skills & Requirements:
- BA/BS degree in a scientific discipline required, Masters or PhD preferred.
- 10+ years of experience in the pharmaceutical industry
- 7+ years of experience in Regulatory labeling
- Strong knowledge of artwork development, review and approval required.
- Labeling experience (CCDS, US, EU, other major markets) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.
The Director, Global Regulatory Labeling will:
- Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
- Direct the labeling control process for tracking, implementation, and regulatory submission of new labeling for US/major markets for the company’s respiratory franchise products.
- Develops labeling content, format and accountability for regulatory submissions (BLAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
- Develops content for artwork related to BLAs and related supplements and amendments. Works with cross-functional team and provides input on new trade names, established names, graphics and logos.
- Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans to the Global Regulatory Science Management Team, Project Development Team and senior management, as relevant.
- Partner with the Global Regulatory Lead to develop Target Label Profiles to support all phases of clinical development.
- Provide input to the end-to-end labeling process.
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.
