Regulatory Affairs Director
An opportunity has arisen for an established Regulatory Affairs specialists to join a biopharmaceutical firm as the Director of Regulatory Affairs. This job role is currently home-based.
- In alignment with global regulatory strategies, assists in the development and implementation of regional regulatory strategies for compounds in all stages of clinical and commercial development.
- Supports strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of drug products in countries within the region.
- Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs.
- Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.
- Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTC's commercial/business objectives.
- Contributes to the organizational design of the regulatory affairs function and contributes to the selection of resources required to meet departmental and corporate objectives. Supports the co-ordination of contracted activities for translation, submission of regulatory documentation and contact with local Health Authorities.
- Performs other tasks and assignments as needed and specified by management.
Skills and Requirements
- Prior experience within working on US regulatory approvals
- Working on regulatory approvals within Oncology
- Strong project management experience, capable of managing a team across the globe
- Experience within biologics / antibodies (nice to have)
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.