Sr Manager Regulatory Affairs Europe
Sr Manager Regulatory Affairs Europe
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Sr Manager Regulatory Affairs Europe
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Job Description Summary
PTC is an established global biopharmaceutical company that strives to deliver transformative therapies for people living with rare diseases. For 25 years we have been harnessing our scientific platforms to create innovative therapies that address the underlying cause of the disease to deliver on our promise to create more moments for those who count on us.
The Senior Manager Regulatory Affairs – Europe is responsible for providing strategic and operational direction for the planning management support and execution of regulatory activities for PTC drug products (clinical and commercial) within Europe This role includes responsibility for support of regional registration and life cycle management regulatory activities. This individual collaborates with the Senior Director Regulatory Affairs Europe the EU Regulatory Team and works closely with the Vice President International Regulatory Affairs Management.
The role is responsible for ensuring that regional regulatory strategies are executed in compliance with current applicable regulations and standards.
This position works crossfunctionally and serves as a liaison between Global Regulatory Affairs team members other PTC departments external service providers and contract manufacturers.
The Senior Manager Regulatory Affairs Europe ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate in alignment with PTC’s global regulatory strategies assists in the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
Job Description
Responsibilities of the role include:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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PTC is an established global biopharmaceutical company that strives to deliver transformative therapies for people living with rare diseases. For 25 years we have been harnessing our scientific platforms to create innovative therapies that address the underlying cause of the disease to deliver on our promise to create more moments for those who count on us.
The Senior Manager Regulatory Affairs – Europe is responsible for providing strategic and operational direction for the planning management support and execution of regulatory activities for PTC drug products (clinical and commercial) within Europe This role includes responsibility for support of regional registration and life cycle management regulatory activities. This individual collaborates with the Senior Director Regulatory Affairs Europe the EU Regulatory Team and works closely with the Vice President International Regulatory Affairs Management.
The role is responsible for ensuring that regional regulatory strategies are executed in compliance with current applicable regulations and standards.
This position works crossfunctionally and serves as a liaison between Global Regulatory Affairs team members other PTC departments external service providers and contract manufacturers.
The Senior Manager Regulatory Affairs Europe ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate in alignment with PTC’s global regulatory strategies assists in the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
Job Description
Responsibilities of the role include:
- Serves as a liaison to regional regulatory Health Authorities and other national authorities and provides guidance and advice on regulatory and policy developments within the region to PTC’s global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.g. new regulations laws etc.).
- 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 and regional/country representatives as necessary to ensure that PTC’s PV obligations within the region are met.
- Performs other tasks and assignments as needed and specified by management.
- Bachelor’s degree in a relevant discipline and a minimum of 3 years of progressively responsible Regulatory Affairs experience in a pharmaceutical biotechnology contract research organization (CRO) or related environment.
- Prior experience helping to build a regional Regulatory Affairs function for a growing organization.
- Indepth knowledge of relevant regional regulatory guidelines and requirements.
- Demonstrated handson experience managing and preparing all phases of regional/country specific regulatory submissions including knowledge of registration procedures in Europe and UK and in particular with the centralized procedure and the EC Reliance Procedure.
- 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 postmarketing and life cycle management activities such as variations renewals and labelling as well as for development activities such as clinical trial applications.
- Experienced providing regulatory support for CTAs and Chemistry Manufacturing and Control (CMC) related activities.
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
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Employment Type
Full Time
Key Skills
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