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Job Details

Senior Manager, Regulatory Affairs Strategy

Company: Regulatory Professionals
Location: Welwyn
Reference: JO-1807-412553
Closing Date: 23 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Regulatory Professionals are collaborating closely with a large pharmaceutical company based in Hertfordshire who are looking for a couple of Senior Managers to join their therapeutic teams.

Requirements:

Senior Regulatory Affairs Manager
Welwyn, Hertfordshire
Job Ref: JO-1807-412553

Regulatory Professionals are collaborating closely with a large pharmaceutical company based in Hertfordshire who are looking for a couple of Senior Managers to join their therapeutic teams. The successful candidate will have extensive life-cycle management from early phase development through to post approval submissions. Furthermore, candidates who have been actively involved from product registration through to product launch of at least one product are highly desirable.

Key Responsibilities:
- Lead the preparation and submittal of Clinical Trial Applications (CTA), Paediatric Investigation Plans (PIP) and Orphan Drug Designations (ODD).
- Involvement in post approval work for Centralised products.
- Close liaison with US counterparts, commercial teams and external partner management
- Authoring and collation of Marketing Authorisation dossiers (MAAs) for global health authority submission.
- Ensuring that Regulatory documentation meets relevant Regulatory requirements and company quality standards.

If you have up to date experience of lifecycle management including initial MAA and post approval submission knowledge then get in touch by sending your CV to josie@regulatoryprofessionals.com or call 0118 9522 797 for further details.

Apply for this job: Senior Manager, Regulatory Affairs Strategy

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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