Description
Regulatory Affairs Manager - £60k-£65k + Benefits - Permanent role - South East England - Global Pharma - Regulatory Global Markets Team.My client is looking for a new member to join the Regulatory Global Markets Team. This established Top Ten Global Pharma wants a committed and driven individual to join at a managerial level. You will be responsible for a team managing the dispersal process of established products across the world. This opportunity offers excellent career progression and creates the perfect platform to make a name for yourself within Regulatory Affairs.
Job responsibilities:
- Plan, manage and execute regulatory activities on licensed products such as submission of variations, renewals, line extensions, responses to Authority - requests, Marketing Authorisation Applications in further countries.
- Handling global Regulatory Affairs maintenance work on licensed products in close collaboration with regulatory counterparts in affiliate companies.
- Interface with regulatory counterparts in affiliate companies as well as internal departments
- Lead staff and teams in the development of alternative regulatory strategies / risk-benefit analyses for pharmaceutical compounds in all phases of clinical development
- Mentors and coaches Regulatory Associates or Senior Associates, Program Managers or Managers, and facilitates their growth and development.
- Supervises 1-3 Associate level and/or professional managerial staff
- Assess need for resources (people, funding and time) and uses available resources efficiently to meet objectives. Delegate appropriately and coaches others toward achievement of goals.
- Plan and coordinate dossier preparation and review of submission documents
- Plan, manage and execute regulatory activities on products such as submission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries
Education and requirements:
- Strong skills in written and verbal communication (in English)
- A degree in pharmacy/life science or similar
- Experience in interactions with European Regulatory Authorities in relation to all aspects of regulatory activities
- Experience of successfully leading and managing teams
- Proven European regulatory submissions capability, in particular in post authorisation activities
Real Pharma are a world leader in placing regulatory affairs professional, with nearly 10 years experience in this market we are specialists who make sure we place the correct candidate in the correct environment.
For more information on this opportunity please contact our Regulatory consultant Ben Moseley on or send you CV to b.moseley(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com