Associate Director/ Director International Regulatory Affairs job in Boston, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP, Officer /Associate, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

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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