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.

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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