Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog

Job Details

Director, CMC Regulatory Affairs

Company: Thornshaw Recruitment
Reference: TD9527
Closing Date: 21 Oct 17
Type: Permanent
Salary (£): Negotiable

Job Summary:

The Director, CMC Regulatory Affairs, will be responsible for providing tactical and strategic regulatory support for marketed products and development programs.


The Director, CMC Regulatory Affairs, will be responsible for providing tactical and strategic regulatory support for marketed products and development programs.    UK or Ireland.

Essential Duties and Responsibilities:

• Develop and effectively communicate US and global drug development and product lifecycle strategies across regions and programs from a regulatory CMC perspective.
• Manage all CMC aspects of new and existing regulatory applications, including INDs, CTAs, NDAs, Marketing Authorizations, and Drug Master Files.
• Author and/or critically review CMC submission documents to support high-quality NDA supplements, MA variations, IND amendments, CTAs, annual reports and DMFs.
• Interface with regulatory agencies as needed, including routine communications, meeting requests, and preparation of supporting documentation.
• Support business development activities related to partnering/distributorship and licensing opportunities, including acting as a regulatory CMC resource for marketing application submissions worldwide and for due diligence assessments of in-licensing opportunities.
• Represent Regulatory Affairs at various project teams and working group meetings, particularly as it relates to CMC regulatory requirements, procedures and activities for the US, Europe and rest-of-world regions.
• Monitor emerging regulatory trends and precedents, and assess and communicate their potential impact on development programs and ongoing lifecycle plans.
• Assist in the oversight and management of external regulatory and development vendor resources, as needed.
• Ensure that all CMC activities are conducted in compliance with applicable regulations and guidelines.
• Coordinate and ensure submissions are prepared and completed to project plans, timelines and budget. 
• Provide regulatory assessment on GMP requirements and questions 
• Review and Draft SOPs, as needed

Job Requirements:
• Bachelor’s Degree in chemistry, biochemistry or other scientific discipline (advanced degree or relevant certification a plus). 
• Knowledge and skills acquired typically through a minimum of 8 years’ relevant industry experience in CMC Regulatory Affairs
• Technical knowledge of and experience with US and European regulations; regulatory knowledge and experience in other regions is a plus
• Experience working effectively in cross-functional teams with other internal and external stakeholders and communicating on behalf of regulatory affairs
• Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.

For further detail contact Tina at +353 1 2784671

Apply for this job: Director, CMC Regulatory Affairs

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.