6 Month Contract - Senior Manager - EU+ Regulatory Life cycle Strategy
As Senior manager, you will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval, in alignment with the EU business strategy.
As Senior Manager- EU Regulatory, you will be responsible for:
Leading the planning, coordination and preparation of regulatory submissions, supporting the EU Regulatory Lead for products post MAA approval
Identify and assess regulatory risks associated with assigned projects and overall product development. Assist in defining strategies to mitigate risks.
Provide leadership and represent regulatory on project teams for assigned projects
Represent the company for defined projects with local and regional regulatory authorities, contractors and corporate partners
Secure alignment between regulatory functions
Provide leadership on project teams and subcommittees in all areas of regulatory science and product development
Provide input to Regulatory Senior Management teams
Provide regulatory guidance to company personnel throughout the research and development process
Lead preparation and participate in specific areas of Health Authority Meetings
Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programs
Build and maintain relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
Responsible for defining strategies for meeting and keeping post approval complianceTo be considered for the role of Senior Manager, you will have the following Experience:
Minimum 5+ years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 2 years in Regulatory Sciences.
EU regulatory experience managing submissions essential.
Experience in interpretation of regulations, guidelines and policy statements.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Some direct experience in interfacing with relevant regulatory authorities.
Foster effective, positive interactions with regulatory agencies, and corporate partners.
Ability to work both independently and with minimal direction and within project teams, committees, etc. to attain group goals.To be considered for the position of Senior Manager, you will be educated to BA/BS/University degree level, Life/Health Sciences preferred.
This is a 6 Month initial contract with the possibility of extension up to 18 months.
Salary rate is depending on experience between £40.00 and £55.00 per hour as a PAYE or Umbrella consultant.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business
Research And Development