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Job Details

Senior Regulatory CMC Manager

Company: Regulatory Professionals
Location: Hertfordshire
Reference: JO-1803-404342_2
Closing Date: 29 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Regulatory Professionals are working with a research based pharmaceutical company who works across the healthcare sector.

Requirements:

Regulatory Affairs Associate Director, CMC
Permanent
Hertfordshire, UK
Competitive salary and benefits package
Job Ref:JO-1803-404342

Regulatory Professionals are working with a research based pharmaceutical company who works across the healthcare sector, aiming to discover and develop innovative medicines worldwide. By primarily emphasising the importance of patient health and wellbeing this company pride themselves in their ethical standards across their broad range of business activities.

By accentuating their values and principles, such as demand innovation and customer satisfaction this differentiates them from their competitive market. Currently, their work across Europe is focused on cancer, Alzheimer’s disease, neurology and other imperative research areas.

Main Responsibilities:
- Accountable for CMC aspects across a variety of projects, including post approval, development, submission activities and response to question from health authorities.
- Prepare and submit IMPD-Q, module 3 for MAA or license variations
- Oversee the CMC aspects for all regulatory submissions (including, but not limited to the following:
- IND or CTA
- NDA or MAA
- Amendments and variations
- 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)
- Scientific background
- A minimum of 8 years of Regulatory experience as well as related experience in R&D or manufacturing
- Authored module 3 documents
- Working knowledge of the application of chemistry principles to drug development
- Experience of process validation and the development of dosage forms

If you meet the outlined requirements and are interested in this position then please feel free to send your CV to josie@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 you’re 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 you’ll receive £250 worth of vouchers of your choice.

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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