Director Regulatory Affairs, E

Proclinical is seeking a dedicated and experienced Director of Regulatory Affairs. This role involves hands-on regulatory activities for a range of products, with the aim of achieving successful registration and life-cycle management. The successful candidate will provide operational and strategic regulatory input to cross-functional teams, ensuring effective communication and constructive working relationships with business partners and regulatory authorities.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Coordinate resources and project support across portfolio products.
• Provide oversight for projects in various therapeutic areas.
• Support on EMA submissions and CTR central submission process and systems.
• Collaborate with management and cross-functional colleagues to provide regulatory insight and broader drug development expertise.
• Act as the primary regulatory liaison with EMA and EU National Competent Authorities.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact.
• Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
• Assess the impact of new regulations, guidances, or enforcements and advise the broader Regulatory Group on compliance requirements.

Key Skills and Requirements:

• Bachelor or Master degree in life sciences in biochemistry, chemistry, biology, or related pharmaceutical fields.
• Experience in the biopharmaceutical industry, ideally in Regulatory Affairs during new drug development.
• Knowledge of USA and EU regulatory pathways.
• Experience with EMA submissions and clinical trial regulations.
• Track record in successful preparation and submission of IMPDs/CTAs, Scientific Advice, MAAs/BLAs, Pediatric plans, Orphan Drug designation, post-approval life cycle management, and supporting GMP inspections.
• Strong knowledge of GMP, drug and biologics development regulations and guidelines including ICH, EMA guidelines, and the Clinical Trial Regulations.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Strong interpersonal and written/verbal communication skills.
• Understanding of GMPs, GLPs, and GCPs; ability to interpret regulatory information.
• Working knowledge of global regulatory requirements and submission processes.
• Good interpersonal skills, ability to lead and influence others, and strong organizational and planning skills.

If you are having difficulty in applying or if you have any questions, please contact Kain Rix on k.rix@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.