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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: Switzerland

Proclinical are currently recruiting for 2 Regulatory Affairs Directors to be based in Zurich to join a global Pharma business. These roles come as part of a departmental restructure which has now created these two roles which we are sourcing exclusively.

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:

Bachelor's degree in a relevant discipline and a minimum of 7 years of progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment with at least 2 years of successful experience in a regional Regulatory Affairs role.
Prior experience helping to build a regional Regulatory Affairs function for a growing organization.
In-depth knowledge of relevant, regional regulatory guidelines and requirements.
Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
Demonstrated success gaining regional regulatory approval and in providing regulatory support for post-marketing and life cycle management activities such as variations, renewals and labelling.

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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