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Associate Director of RA

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
3 Jan 2023
Closing date
2 Feb 2023
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Job Details

On behalf of our client, a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, we are currently recruiting for an Associate Director of Regulatory Affairs.

Seeking a highly-motivated professional who is looking to grow their career with the company.

About the Position

The Associate Director, Regulatory Affairs (EU) will be responsible for leading regulatory efforts for early through late stage products, including marketing applications. Regulatory representation on cross-functional teams, oversight of routine and key submissions in Europe and globally, and leading Regulatory Agency interactions are within the scope of this role.

This position will report to the Executive Director, Regulatory Affairs and will be based in Dublin, Ireland.

Key Responsibilities

  • Develop strategy for and oversee the preparation of global regulatory submissions including clinical trial applications, their amendments, and other regulatory documents including orphan drug applications, and Paediatric Investigation Plans (PIP) Lead clinical trial applications (CTAs) as well as EU Marketing Authorisation Applications (MAA)
  • Coordinate and manage responses to Regulatory Agency queries in a timely manner
  • Act as the sponsor contact with Health Authorities Prepare documents for and lead Regulatory Agency interactions
  • Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure execution of the regulatory strategy
  • Develop and implement regulatory strategies to meet project deliverables and mitigate potential regulatory risks
  • Contribute to establishing department processes and participate in SOP and other process development Work with development partners

Qualifications and Experience

  • Minimum 7 years of relevant industry experience in with drug or therapeutic biologic products. Experience in oncology strongly preferred.
  • BS in a life sciences discipline; advanced degree preferred but not required
  • Experience in the preparation of regulatory documentation to support CTAs, MAAs; oversight of CROs or contractors
  • Requires knowledge of global health authority regulations and guidelines with a focus on EU, UK and ICH
  • Strong technical/analytical skills to identify and solve problems independently
  • Proven ability to manage multiple projects, identify and resolve regulatory issues
  • Excellent organizational skills, able to work on a number of projects under tight timelines
  • Excellent verbal and written communication skills for effectively interfacing with all levels of management and departments within the company
  • Ability to work independently with minimal supervision or direction

For full details contact Linda at +353 1 2784703 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

Company

Thornshaw Scientific Recruitment has been providing a reputable recruitment service to the Biopharmaceutical, Pharmaceutical, Clinical Research, Medical Device, Food and Healthcare industries for over 15 years.

Our strategic focus has always been to grow the business in a way which has ensured the quality of our service has never been compromised. In 2005 Thornshaw was acquired by Cpl Resources, one of Europe’s most successful recruitment companies.

Find Us
Website
Telephone
00 353 (1) 278 4671
Location
Barton House
6 Old Dublin Road
Stillorgan
Co. Dublin
IE
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