Senior Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma
- Company
- Turner Regulatory
- Location
- Cambridge/Hybrid working, UK
- Salary
- Competitive
- Posted
- 28 Sep 2022
- Closes
- 20 Oct 2022
- Ref
- W1HMj6lurFJT
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Senior Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma
Exciting Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location with some Hybrid Working. New Registrations (new launches) and Post approval. Regulatory CMC - Modules 2.3 and 3 Authoring. ROW/Emerging Markets - LATAM, Africa, Middle East, Asia/Pacific. All National Submissions.
This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Pharma Products with one Biologic. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration.
The candidate will have expertise in Regulatory CMC Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in ROW/Emerging Markets. The candidate will possess good Regulatory CMC pipeline experience, but with specific strengths in New MAA's and Post approval: Module 3 & 2.3 Authoring, Variations, etc. All National Submissions.
The company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day management of Projects. The candidate will need to have a substantial background in Regulatory Strategy, ideally: CTD/Dossiers for MAA's (Module 3 and 2.3 writing); National Submissions; Regulatory Intelligence exposure and Scientific Advice meetings would be beneficial.
The successful candidate will possess a solid Regulatory CMC background within Pharmaceutical or Biologics or of at least 7+ years. The candidate will demonstrate solid Project Management skills.
This position is based in Cambridge, and may require some travel, as necessary. Hybrid working is permitted.
A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other benefits.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application by clicking Apply Now.
Exciting Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location with some Hybrid Working. New Registrations (new launches) and Post approval. Regulatory CMC - Modules 2.3 and 3 Authoring. ROW/Emerging Markets - LATAM, Africa, Middle East, Asia/Pacific. All National Submissions.
This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Pharma Products with one Biologic. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration.
The candidate will have expertise in Regulatory CMC Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in ROW/Emerging Markets. The candidate will possess good Regulatory CMC pipeline experience, but with specific strengths in New MAA's and Post approval: Module 3 & 2.3 Authoring, Variations, etc. All National Submissions.
The company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day management of Projects. The candidate will need to have a substantial background in Regulatory Strategy, ideally: CTD/Dossiers for MAA's (Module 3 and 2.3 writing); National Submissions; Regulatory Intelligence exposure and Scientific Advice meetings would be beneficial.
The successful candidate will possess a solid Regulatory CMC background within Pharmaceutical or Biologics or of at least 7+ years. The candidate will demonstrate solid Project Management skills.
This position is based in Cambridge, and may require some travel, as necessary. Hybrid working is permitted.
A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other benefits.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application by clicking Apply Now.