Clinical Trial Submissions Manager

Hybrid working 2x a week

Scope:

This is an excellent opportunity for an experienced Clinical Trial Submissions Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase in the production of pharmaceutical. They are looking for someone with EU CTR/CTD/CTIS/CTA experience who is looking for a new opportunity to grow and develop their career.

Responsibilities:

• Develop and execute CTA regulatory strategies and operations for a designated portfolio of developmental compounds across specified regions: WE, EEMEA, LA, and select JAPAC countries, ensuring alignment with global regulatory strategies and regional requirements
• Design and implement regulatory strategies and deliverables for global clinical trial applications in accordance with the overarching global regulatory strategy considering regional specific requirements
• Coordinate submission strategies for global clinical trials, ensuring alignment with regulatory strategies, and promptly highlighting any risks or issues to GRPT and study teams
• Ensure timely achievement of study deliverables in accordance with global regulatory strategies and evolving global clinical trial legislation, including compliance with the EU Clinical Trial Regulation and company protocols
• Serve as the primary liaison between the company and regulatory authorities for streamlined assessment procedures
• Act as main interface between global subject matter expert functions and affiliates to implement clinical development regulatory strategies and achieve desired outcomes
• Populate and manage regulatory databases to oversee data collation, and track regulatory submissions

About You:

• Possesses a minimum of 6 years' experience in the pharmaceutical industry, with a focus of at least 5 years in Regulatory Affairs, including extensive involvement in global clinical trials.
• Demonstrates experience in overseeing multinational programs of Clinical Trial Applications (CTAs).
• Exhibits a comprehensive understanding of global clinical trial legislation, including but not limited to the EU Clinical Trials Directive, Voluntary Harmonization Procedure, Clinical Trial Regulation, as well as familiarity with evolving regulatory environments, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), ICH guidelines, and other relevant protocols related to clinical trial supply management.
• Preference for knowledge and experience in medical device legislation relevant to clinical trials.
• Holds a degree in medicine, pharmacy, biology, chemistry, pharmacology, or a related life sciences discipline.