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Job Details

Regulatory Affairs Senior Manager - CMC

Company: Regulatory Professionals
Location: Cambridgeshire
Reference: J32454
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: Circa £80,000/£95,000 per annum package.

Job Summary:

Regulatory Affairs Senior Manager - CMC Regulatory Professionals collaborating with a leading international pharmaceutical company who are looking for Regulatory CMC experts.

Requirements:

Regulatory Affairs Senior Manager - CMC
Location: Cambridgeshire
Permanent positions
Salary: Flexible dependant on experience. Circa £80,000/£95,000 per annum package.
Job Reference number: J32454

Regulatory Professionals collaborating with a leading international pharmaceutical company who are looking for Regulatory CMC experts. The successful applicant will be managing assigned regulatory CMC activities and providing strategy advice for their expanding portfolio.

Responsibilities include:
* Providing expert CMC strategy and advice to assigned projects
* Preparing CMC documentation to support clinical trial applications and market authorisations
* Assist with MA maintenance e.g. renewals and variations
* Successfully manage Regulatory CMC and compliance activities.
* Evaluate due diligence activities and business development projects
* Providing input into development project strategies and support ongoing developments.
Requirements;
* 7+ years Regulatory experience
* Ability to mentor, guide and potentially line manage team members
* In depth knowledge and experience in CMC documentation and authoring activities
* Ability to build internal and external relationships
* Experience working on Global markets
* Prior experience working with Inhalation/ Respiratory or Class III Medical Device product would be advantageous.

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

Regulatory, Regulator Senior Manager, CMC, Chemistry Manufacturing Control, Strategy, MA, Cambridge.

Apply for this job: Regulatory Affairs Senior Manager - CMC

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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