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Job Details

Senior Regulatory CMC Manager

Company: Regulatory Professionals
Location: Hatfield
Reference: JO-1901-422571
Closing Date: 18 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Regulatory Professionals are working with a research-based pharmaceutical company who are currently looking for a Senior CMC Regulatory Manager.

Requirements:

Senior Regulatory CMC Manager
Permanent
2 days home-working
Hertfordshire, UK
Competitive

Regulatory Professionals are working with a research-based pharmaceutical company who are currently looking for a Senior CMC Regulatory Manager. The objective of the role is to reduce medicine development periods by assessing the current status of CMC-regulatory information.

Main Responsibilities:
- Accountable for CMC aspects across a variety of projects, including post approval, development, submission activities and response to question from health authorities.
- Oversee the CMC aspects for all regulatory submissions (including, but not limited to the following:
o IND or CTA
o NDA or MAA
o Amendments and variations
o Scientific advice briefing documents
- Provide insight to regulatory strategy and manage project timelines

Application Requirements:
- Degree educated in an associated discipline (i.e. Chemistry or Pharmacy)
- Authored module 3 documents
- Working knowledge of the application of chemistry principles to drug development
- Experience of liaising with agencies to hold meetings related to quality.

If you meet the outlined requirements and are interested in this position then please feel free to send your CV to anusha.tabari@regulatoryprofessionals.com or if you have any questions regarding the role then please call 01189 522 797.

If this role is not quite right for you, but youre interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then youll receive 250 worth

Apply for this job: Senior Regulatory CMC Manager

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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