Senior Director, Regulatory Affairs EU

Founded in 1998, PTC Therapeutics is a global biopharmaceutical company focused on discovery, development and commercialization of innovative treatments that bring benefits to patients suffering from rare diseases.

For more than 25 years, PTC have been harnessing its scientific platforms to deliver a number of life-changing therapies to patients that address the underlying cause of multiple rare diseases.

PTC has a footprint in more than 50 countries and offices in 20 countries around the world.

The Senior Director, Regulatory Affairs EU is responsible for leading strategically and operationally the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the European region (including UK and Switzerland). This role includes responsibility for support of EU regional registration and life cycle management regulatory activities. This individual is responsible for guiding the European Regulatory Affairs team in their duties. She/He 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. He/she manages direct reports.Job Description:

Responsibilities of the role include:

• In alignment with PTCs global regulatory strategies, leads the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
• Serves as a liaison to regional regulatory Health Authorities including the European Medicines Agency (EMA), the UK MHRA, The SwissMedic Agency and other national authorities and provides guidance and advice on regulatory and policy developments within the region to PTCs global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.g. new regulations, laws, etc.).
• Defines 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.
• Provides guidance to EU team Regulatory Team Members in the executing of their projects, strategically and operationally.
• Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTCs commercial/business objectives.
• Provides regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that PTCs PV obligations within the region 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.

Requirements for the role include:

• Experience in rare or orphan disorders research (small patient populations coupled with urgent unmet medical need).
• Recent in-depth experience with the Centralized Registration Procedure.
• In-depth knowledge of relevant, regional regulatory guidelines and requirements for application in an emerging regulatory landscape.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Demonstrated, hands-on experience leading, managing and preparing 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.
• Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

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