Job Details


Director, EU Regulatory Affairs

Title: Director, EU Regulatory AffairsJob ID: BM556780918Location: Cranbury, NJWe are looking to hire a Director, EU Regulatory Affairs. This person is a hands-on team player that enjoys working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. The ideal candidate is an action-oriented, life-long learner who is inspired to make an impact for patients. The Director for EU Regulatory Affairs will lead the development and implementation of the EU regulatory strategy for the organization’s gene therapy programs in accordance with EU regulations and through collaboration with external partners, internal cross-functional teams, and global health authorities.Responsibilities:Lead the development and implementation of the EU regulatory strategy across the company’s gene therapy pipeline, in coordination with the overall global regulatory strategy to support efficient development and approval of their gene therapy productsOwn the development and timely submission of high-quality regulatory documents to EU health authorities Serve as the primary point of contact with EU regulatory agencies, including leading formal and informal meetings with relevant agencies and responding to health authority inquiriesStay abreast of, analyzes, and effectively communicates relevant changes to the EU regulatory landscape to the managementPerform other duties as assignedQualifications:Strong scientific backgroundBA/BS/University degree in Life/Health Sciences required; advanced degree preferred (PharmD, MD, PhD, JD)6+ years of EU regulatory experience with a premarket focusCell and gene therapy experience strongly preferredProficient with other international regulations, including ICH guidelinesStrong leader but also strong team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solveAbility to thrive in a fast-paced environmentStrong writing skills is a must, including ability to author documentsAbility to communicate effectivelyFor more information about TEEMA and to consider other career opportunities, please visit our website at

Job Category:  [ View All Jobs ]
Experience (years): Unspecified
Job Location: Cranbury, NJ USA
Job Location Zip/Postal Code 08512
Posting Company Type Employer
Post Date: 01/13/2021 / Viewed 0 times
Contact Information
Company: TEEMA

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