Job Description Director, Regulatory Biologics
Essential Pharma are looking for a Regulatory Biologics Director. This role is responsible for formulating and executing regulatory strategy for products, mainly within biologics, both in development and lifecycle management. It will have you leading and coordinating Regulatory Affairs activities cross functionally both in-house and through contractors. Apply today!
What You Will Do
Principal duties:
Lead all aspects of Biologic Product regulatory activities as a subject matter expert
Establish regulatory priorities and coordinate where required with Regulatory Affairs consultants, Quality, Manufacturing, Science & Technical (MSAT), Pharmacovigilance and Medical Affairs teams, to drive the effective submission, approval, and implementation processes for the product range.
Lead regulatory activities of new biologic products acquisitions advising on transfer of Marketing Authorisations (MA) or lead the development of regulatory strategies and implementation plans for the preparation and submission of new products.
Drive positive interactions with Regulatory authorities (e.g. MHRA, EMA, US FDA) to ensure smooth submission
Oversee and execute high quality submissions, aligning with internal stakeholders.
Operate internally and externally fulfilling the need...