Regional Strategist - CMC
This is an excellent opportunity to work for a global leader in the life sciences industry. The company is currently looking for a Regional Strategist CMC in South East England. The company has been established for more than 150 years and is a major supplier to the NHS.
- Manage initial and post approval submissions for products in Developed Market
- Manage initial and post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL, CRL, Labelling team, Submissions Management) to ensure a submission ready dossier.
- Communicate changes to regulatory requirements and update the appropriate system in a timely manner
- 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
- Liaise with the manufacturing sites for obtaining supporting documents as needed
- Assist in ensuring internal regulatory processes and procedures are well documented
- Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
- Understand local regulations and trends for assigned markets
Skill and Requirements
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
- Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution.
- 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.
- Communication skills
- Negotiation and influencing skills
- Understanding stakeholder needs
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies