Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Manager/Associate Director - Regulatory Affairs 

Company: RBW Consulting
Location: Seattle, Washington
Reference: RAA-SMADRA-SWA
Closing Date: 10 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:

Senior Manager/Associate Director - Regulatory Affairs 

Seattle, Washington

Job Description:

The incumbent will closely interact with multiple functions to create high quality regulatory submissions that support the client’s product development strategy.  The ideal candidate is someone who is comfortable with a fast-paced work environment with other high performers.  This person should be an innovative thinker, good problem solver and someone looking to expand their limits.  Key activities include (or may include):

  • Providing input to regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices
  • Provide regulatory expertise and guidance to cross functional teams on regulatory requirements for global development and market registrations
  • Experience with clinical trial (IND/CTA) and marketing application (BLA/NDA) filing requirements including content requirement, technical writing, and tracking timelines.  Ensure the development of high quality submissions
  • Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings
  • Staying abreast of and reporting on emerging regulatory intelligence and/or activities, such as new/revised regulations and regulatory guidances, competitive product applications, designations and/or approvals, and advisory committee meetings and their outcomes
  • Representing the regulatory affairs function in project teams to provide regulatory support and advice
  • Interacting with corporate partners regarding various regulatory matters
  • Providing support for regulatory interactions, including meetings and teleconferences
  • Drafting and/or modification of applicable SOPs and/or other written practices relating to the regulatory affairs function
  • Shows good judgment to determine when to escalate problems to his/her superior
  • Cross-site travel will be required as needed

Basic Qualifications:

  • Bachelor’s degree (or equivalent) in a science-related discipline (e.g., biology, chemistry, microbiology, immunology)
  • 8+ years experience in a regulated industry
  • Experience in oncology and rare diseases preferred
  • Strong working knowledge of U.S. regulatory requirements for biologics
  • Excellent written and oral communication capabilities, with particular attention to detail
  • Highly organized, independent, and self-motivated with ability to multi-task
  • Strong time and project management competency, with the ability to meet deadlines
  • Experience with eCTD – electronic documents and submissions
  • Demonstrated ability to work within a cross-functional team and in a matrix environment

Preferred  Qualifications:

  • Experience with NIH Appendix M submissions
  • Experience with ex-U.S. regulatory submissions
  • Experience in Immunology, especially with cell and/or gene therapy products a plus
  • High degree of proficiency with MS Office applications (including MS Word, MS Visio, MS Powerpoint) and Adobe Acrobat 

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: Senior Manager/Associate Director - Regulatory Affairs 

Contact Information:

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.