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Job Details

Director, CMC Regulatory Affairs

Company: Thornshaw Recruitment
Location:
Reference: TD9527
Closing Date: 15 Sep 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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

Requirements:

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:
Education:
• Bachelor’s Degree in chemistry, biochemistry or other scientific discipline (advanced degree or relevant certification a plus). 
Experience:
• 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

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