Regulatory Affairs Senior Associate / Project Manager / Lifecycle
- Recruiter
- Turner Regulatory
- Location
-
United Kingdom
United KingdomUnited Kingdom
- Salary
- Competitive
- Posted
- 15 May 2022
- Closes
- 10 Jun 2022
- Job Title
- Associate Director
- Category
- Public Sector
- Contract Type
- Permanent
- Hours
- Full Time
Regulatory Affairs Senior Associate / Project Manager – Change Lead. Are you already a Senior Regulatory Associate focusing on Life–cycle management? If so, this is the opportunity you have been waiting for.
This Regulatory Affairs Change Lead, Life–cycle Change Management, is for a fast–growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas.
Reporting to the Regulatory Affairs Change Team Leader, you will Project Lead and Manage in Post approval activity. You will be responsible for the Life–cycle Changes. You will ensure prioritisation, planning and execution of Post Marketing activity across the Product Portfolio. You will liaise with Regulatory Managers and Service providers to ensure effective implementation and effect plans to harmonise how Regulatory Projects are managed and improved.
Technically, you will have good working knowledge and experience of Registrations and Post marketing activity/Life–cycle management; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan–European and some International territories.
An excellent salary package awaits the successful candidate. Northwest London Location but hybrid working arrangements.
Candidates from a Pharma or Biologics background in European & International Regulatory Life–cycle management with approximately 5 years' experience, and good mentoring skills should be suitable for this position.
You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on / or by clicking Apply Now.
This Regulatory Affairs Change Lead, Life–cycle Change Management, is for a fast–growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas.
Reporting to the Regulatory Affairs Change Team Leader, you will Project Lead and Manage in Post approval activity. You will be responsible for the Life–cycle Changes. You will ensure prioritisation, planning and execution of Post Marketing activity across the Product Portfolio. You will liaise with Regulatory Managers and Service providers to ensure effective implementation and effect plans to harmonise how Regulatory Projects are managed and improved.
Technically, you will have good working knowledge and experience of Registrations and Post marketing activity/Life–cycle management; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan–European and some International territories.
An excellent salary package awaits the successful candidate. Northwest London Location but hybrid working arrangements.
Candidates from a Pharma or Biologics background in European & International Regulatory Life–cycle management with approximately 5 years' experience, and good mentoring skills should be suitable for this position.
You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on / or by clicking Apply Now.