Associate Director/ Director International Regulatory Affairs

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Officer /Associate, RA Intelligence
  3. United States
Boston, USA
Posting date: 12 Jun 2020
RA.FG.29977
This vacancy has now expired

Proclinical is currently recruiting for a Director of International Regulatory Affairs for a leading biopharmaceutical company located in Boston, MA. As the International Regulatory Affairs Director, you will lead and/or participate in cross functional and cross company interdisciplinary teams responsible for defining and implementing regulatory strategy.

Job Responsibilities:

  • Lead/participate in cross functional and cross company interdisciplinary teams establishing International regulatory strategy for commercial products.
  • In conjunction with company partners or regional leads and experts, oversee planning, preparation, submission and maintenance of marketing applications to support LATAM, MEA and APAC regions ensuring compliance with local; regulations and guidelines.
  • Provide proactive regulatory intelligence in areas of a competitive nature and keep abreast of changes in agency regulations and requirements
  • Provide strategic regulatory insight to Global Regulatory Leaders, Core Product Teams and peers to expedite approval of pending registrations
  • Provide regulatory guidance regarding preparation, review and approval of labeling.
  • Manage regulatory interactions with distributors, consultants or partners
  • Provide input into development of processes to leverage the company's existing processes and infrastructure and maximize efficiency and effectiveness.

Skills and Requirements:

  • Bachelor's degree in a Life Science or related field preferred.
  • 10+ years of experience in regulatory/quality or related departments within the pharmaceutical industry.
  • 3-5+ years' management experience.
  • Must be detail oriented with well-developed organizational and analytical skills.
  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment.
  • Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively.
  • Experience with electronic document management systems.
  • Effective communicator of technical & non-technical information.
  • Ability to work in a self-directed manner to see issues through to completion.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbudamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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