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Job Details

Director, Regulatory Affairs

Company: RBW Consulting
Location: Cambridge
Reference: RAA-DRA-CMA
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Director, Regulatory Affairs

Cambridge, MA

The Director RA role is a strategic leadership role within the US and Regions regulatory team. The role contributes to the vision and goals for Global Regulatory Affairs, by providing regional strategic advice and support to Project/Product teams, Regulatory CMC & Compliance and Regions Commercial Operations and Business Development teams.


The role interfaces with other functions in Regulatory Affairs (e.g. Global Regulatory Leads, Regulatory CMC & Compliance, Regulatory Operations & Compliance,) and across the organization in Commercial Operations and Business Development, to ensure collaborative connectivity with these key stakeholders, and a focused regulatory approach to supporting country and regional business objectives, or global R&D objectives.


The Senior Manager, US & Regions will influence, lead and execute the regulatory strategy for one or more products. The role will ensure high quality submissions and that all dossiers are up to date and compliant and that regulatory commitments are fulfilled.


The Senior Manager, US & Regions will have direct reports who are co-located on site, and will be responsible for the planning and oversight of the work to be conducted by their reports, and for the “on the job” training and coaching of their reports.

  • Formulate, lead and drive the regulatory Strategy for company products in the Region      
  • Lead and oversee the preparation, compilation and submission of high quality applications in the Region including marketing authorisation applications, variations, renewals, responses to questions and regulatory agency briefing documentation      
  • Support Business Development in the regulatory assessment and due diligence of new market opportunities in the Region     
  • Build strong and credible relationships with partners / agents in Regional markets      
  • Actively contribute to the global company regulatory community through designated projects.      
  • Work closely with the RA Regions Head to develop and maintain an effective Global Regulatory Affairs organisation through continuous improvement initiatives that deliver business excellence.      
  • Manage the functional budget, resource plans and monitor progress of the Regulatory team to ensure strategic objectives for the Region are achieved      
  • Identify opportunities and contribute to the growth and professional development of direct reports (if applicable)      
  • Deputise for RA, Regions Head as required   
  • Develop collaborative and respectful relationships with staff at CBER/FDA and other National Human Medicines Regulatory Agencies within the Region & represent the client at meetings with these Regulatory Agencies

Education

  • A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Masters or PhD, or complementary experience in the pharmaceutical/ biotechnology industry.
  • 7-10 years’ regulatory experience with extensive knowledge and experience of US regulatory affairs and working with CBER/FDA . Experience in biologicals is advantageous.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Director, Regulatory Affairs

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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