Associate Director of Regulatory Affairs EU
A new vacancy has arisen for an Associate Director of Regulatory Affairs EU. This position can be based in any European office with the option to also work from home. The role is responsible for ensuring that regional regulatory strategies are executed in compliance with current, applicable regulations and standards.
- 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.
- Provides regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that PTC's PV obligations are met.
- 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, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions including knowledge of National, Mutual Recognition and Decentralized/Centralized procedures.
- 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.
In case you have difficulty in applying or if you have any questions, please contact Joe Dykes on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.