Regulatory Manager, Clinical Trial Strategy & Submissions

Description:

SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead.

The Role:

Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified geographic region.
Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team and study teams.
Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial and company procedures.
Primary interface between Company and regulators.
Populate and maintain regulatory databases, data collation and tracking of regulatory submissions.
Participate in development of internal working procedures.
Represent regulatory perspective in cross functional process improvement initiatives.

Key Responsibilities:

In accordance with the overarching global regulatory strategy considering regional specific requirements.
Represent area regulatory in clinical trial planning meetings and provide strategic and operational support for Company CTAs for Company sponsored clinical trial Primary interface to and from affiliate personnel in over 60 countries.
Primary interface between Company and regulators for harmonized assessment procedures and with local health authorities.
With support from the Associate Director, provide regulatory interface concerning clinical trials with cross functional teams in the to identify, resolve and elevate potential issues.
Work in close collaboration with Global Regulatory Leads and subject matter experts to ensure clinical trial deliverables are executed.
Support internal and external GxP inspections.
Leads project teams effectively to escalate and drive resolution of project issues.
Effectively frames complex issues for decision-makers.
Supports the Associate Director with planning and tracking of regulatory activities and agency interactions.

Experience Required:

Minimum of 3-5 years' experience in the pharmaceutical industry with at least 5 years' experience in Regulatory Affairs including extensive global clinical trial experience.
Experience of managing multi-national programmes of CTAs
Excellent understanding of the legislation governing the conduct of global clinical trials and evolving regulatory environment, Good Manufacturing Practices and Good Clinical Practices, ICH and other pertinent guidelines.
Knowledge and experience of medical device legislation in relation to clinical trials is preferable.
A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy