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First Name*

Last Name*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: United Kingdom

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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