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 Director, Global Regulatory Affairs - CMC

Company: RBW Consulting
Location: Pleasanton, CA
Reference: RAA-SDGRACMC-PCA
Closing Date: 11 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:

Senior Director, Global Regulatory Affairs - CMC 

Pleasanton, CA

The Senior Director, Global Regulatory Affairs - CMC will support oncology development programs, provide CMC regulatory expertise and support for development project work including CMC regulatory review for regulatory submissions and regulatory processes. This individual will represent CMC Regulatory Affairs on Project Teams, participate on Regulatory Submission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that clinical trials are designed to meet regulatory requirements, and guide programs to registration submissions.

Responsibilities:

  • Work closely with CMC colleagues to develop CMC regulatory submission strategies, review content, and maintain submission timelines to meet business objectives
  • Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
  • Lead efforts for coordinating CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications and NDAs
  • Work with department management on CMC plans for NDA/MAA submissions and lead Module 3 preparation
  • Take a lead role in company preparations for Regulatory Agency meetings with CMC focus
  • Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and Background Documents for Regulatory Authority meetings
  • Work with regulatory organizations and partners Europe and Asia to prepare applications, respond to queries to enable maintenance of CMC needs for clinical activities outside of the United States
  • Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues
  • Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy and specification committee meetings
  • Assure compliance with regulatory standards and guidance documents
  • Prepare, submit, track, index, and archive electronic submissions
  • Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements
  • Conduct risk assessments of global CMC regulatory issues
  • Liaise with Medical Writing for coordinating and publishing submission documents
  • May include management of department staff and vendors

Qualifications:

  • PhD or PharmD in life sciences with 8+ years of CMC regulatory affairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatory affairs experience
  • Experience at the development (IND/CTA) and registration (NDA/MAA) stage
  • Experience with regulatory health authority interactions in North America and Europe
  • Experience with small molecule, oncology drug development desirable
  • Knowledge of the drug development process, drug laws, and global regulations and requirements required
  • Strong analytical skills, problem solving ability and presentation skills required
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously
  • Preference to manage projects
  • Effective oral and written communication skills
  • Broad background and ability to work and influence across multiple functions
  • Proficiency using Microsoft Office products and electronic systems required; experience with documentation systems and publishing tools a plus
  • Familiarity with project management principles is a plus

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 Director, Global Regulatory Affairs - CMC

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.