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.

Job Responsibilities

• 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)

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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