The Role: To provide RA leadership on product lifecycle management (change management) and global product registrations. Provide support for initiating and tracking impact assessments for...
Accountable for supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.
Ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
Manage initial and post approval submissions for assigned markets & and execution in alignment and partnership with key stakeholders to ensure a submission ready dossier.
Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners.
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness and author local submission components as needed.
Liaise with the manufacturing sites for obtaining supporting documents as needed.
Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
Skills & Qualifications:
Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation.
Knowledge of drug development practice, rules, regulations and guidelines.
Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
Regulatory experience including knowledge of Europe submission product lifecycle management processes.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.