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