Senior Regulatory Affairs Manager, Slough
This role is with Pro4orm People Ltd, based in Slough, United Kingdom, and requires an EU work permit. The position is full-time and permanent, based in Berkshire three days a week.
Job Overview
We are seeking an experienced Senior Regulatory Affairs Manager with a strong understanding of European Regulatory requirements to support a global pharmaceutical company's development and registration processes within the EU.
Key Responsibilities
* Provide strategic regulatory and scientific support for non-clinical and clinical development plans to facilitate rapid access to innovative medicines.
* Contribute regulatory input into development programs and registration documentation, ensuring compliance with relevant guidelines.
* Identify and analyze applicable guidelines for product development and registration in Europe.
* Assess data critically, identify gaps, and prepare submission documentation.
* Participate in due diligence of dossiers, assessing modules 1 to 5, and respond to review questions.
* Collaborate with internal and external stakeholders to finalize Marketing Authorization Applications (MAA).
Requirements
* Deep understanding of European regulatory requirements, especially for specialty products in highly regulated territories.
* Skills in influencing, problem-solving, project management, adaptability, teamwork, and intercultural communication.
* Degree or higher in pharmacy, life sciences, or equivalent.
* Experience with Regulatory Affairs tools and software such as eCTD, CESP, MHRA portal, Eudralink, and Microsoft Office.
Application reference: 690852. Pro4orm People Ltd is an Equal Opportunities Employer. We will contact successful applicants within 5 working days. By applying, you agree to our Terms and Conditions and Privacy Policy.
Commitment to Diversity: We welcome applications from all qualified candidates regardless of race, gender, sexual orientation, religion, disability, or background.
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