Associate Director/ Director International Regulatory Affairs
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.
- 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 firstname.lastname@example.org.
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.