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Job Details

Manager, Regulatory Affairs

Company: RBW Consulting
Location: Waltham, MA
Reference: RAA-MRA-WMA
Closing Date: 04 Jan 18
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:

Manager, Regulatory Affairs

Waltham, MA

Role Outline:

This is an exciting opportunity for an individual interested in playing a key role in Regulatory Affairs in development programs for personalized medicines.  This individual will develop a broad regulatory experience in both biologics and small molecules drug development, as well as obtain some exposure to companion diagnostic submissions. You will be responsible for leading clinical and nonclinical related agency correspondence and regulatory applications (IND and CTA) to support global oncology clinical trial programs. 

Job responsibilities:

  • Manages regulatory global clinical/nonclinical submission plans for  early and late phase product development projects with an emphasis on EU CTA management
  • Offers submission strategies for development products and identifies potential regulatory risks
  • Represents Regulatory  on interdisciplinary teams 
  • Provides interpretation of regulatory guidance documents, regulations and directives; and advises on applicability and impact on internal programs. 
  • Communicates critical topics to appropriate management level

Job Requirements:

  • Minimum BS in scientific discipline, advanced degree a plus – ie: M.S., MBA, PhD. 
  • Minimum of 3 years of pertinent experience in the pharmaceutical/biotech/medical device industry, including preparation of initial INDs, CTAs, DSURs and meeting briefing documents in US,  and ex-US
  • Strong knowledge of  US and EU regulations and Guidance pertaining to the conduct of investigational drug studies
  • Experience in oncology programs a plus, although not required
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Strong verbal and written communication skills
  • Strong project and submission management skills

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: Manager, 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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