CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company remote or at their site based in Uxbridge on a contract basis for 12 months.Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Location:
This Regulatory Affairs Senior Manager role will be either remote or based at our clients site in Uxbridge, Greater London. Salary:
Competitive.Regulatory Affairs Senior Manager Role:
- Define and advise the Global Regulatory Team (GRT) on regional considerations in developing creative regulatory strategy.
- Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Develop and implement regulatory strategy and executional plans, and manage regulatory submissions (e.g. clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements.
- Lead development of regional regulatory documents and meetings, and provides regulatory advice on regional regulatory requirements, mechanisms to optimise product development and to maintain compliance.
- Co-ordinate and provide guidance to company responses to requests from regulatory authorities, e.g. Response to Questions (RTQs).
- Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans.
- Practical Regulatory knowledge of regional legislation.
- Working with policies, procedures and SOPs.
- Experience with national legislation and regulations relating to medicinal products.
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Experience in oncology therapeutic area is preferred.
For more information or to apply for this Regulatory Affairs Senior Manager position, please contact Lucy or Andy on 01438 870011 or email email@example.com, quoting job ref 48953.
It is essential that applicants hold entitlement to work in the UK.