Director, Regulatory Affairs (Clinical) - Lexington, MA

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Active since 22-03-2017 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Master / Post-Graduate / ... Employment type -
Hours 40 Salary Competitive

Place in the Organization:

Regulatory Affairs ensure our products meet the appropriate legislation in order to control their safety and efficacy from early development phases up to the coordination of approval and registration. Regulatory Affairs are the crucial link between our company, our products and the regulatory authorities and they advise on and coordinate the development and approval of our products.

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so, each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Key result areas (major duties, accountabilities and responsibilities):

  • Execution of global registration strategies for all uniQure’s pipeline products and support activities in the therapeutic area of the central nervous system.
  • Assisting in the design and analysis of Clinical Studies to support Regulatory Approvals.
  • Development of promotional, advertising, and labeling items.
  • The preparation and submission of Clinical Trial Applications (CTAs), Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug Applications (IND) and other submissions, as required.
  • Representing the Company at meetings with Regulatory Authorities.
  • Securing close regulatory interactions globally throughout the lifecycle of uniQure’s pipeline projects to secure the development of appropriate development plans, Paediatric Investigational Plans (PIPs), Liaising closely with uniQure’s commercialisation partners.
  • Following the emergence of new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline.
  • Providing counsel, training, and interpretation of global regulatory agencies and other regulatory issues to Company personnel and assisting as a liaison between the Company and Regulatory Authorities.
  • Participation in industry association committees and initiatives as a scientific expert, as appropriate, to represent and defend the company’s interests.
  • Developing and maintaining contacts with global Regulatory Authorities to represent and defend the company’s interests and the building of a regulatory network of competent partners.


Qualifications & Skills:

  • 8-10+ years of Regulatory Affairs experience, Bachelor or a higher scientific degree (MS, PharmD, PhD).
  • 5-10+ regulatory experience in the biotech/pharmaceutical industry in both the pre-market and post-market setting.
  • 5-10+ years experience in therapeutic products (preferably biologics/vaccines/advanced therapeutics).
  • Experienced in leading EU Regulatory Agency meetings resulting in successful regulatory approvals, including product defense experience for products marketed in the EU.
  • Experience with international regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations.


Core competencies:

  • Demonstrated people management experience, and development/growth and retention of talented personnel, differentiating performance and rewarding accordingly.
  • Excellent oral and written communication skills - invaluable in communicating with global, cross functional, cross-cultural, multi-disciplinary project teams including team members in country offices.
  • Experienced in communicating vertically and horizontally within an organization and with necessary cultural awareness and sensitivity.
  • Respectful and collaborative team player with both line and matrix management experience.
  • Ability to rapidly understand and analyze complex problems/situations; active participation and the management of projects leading to solution development and implementation.
  • Record of influencing project teams, strategically, operationally and delivering on budget and within agreed upon timelines.
  • Involved in implementing and optimizing corporate strategies globally, thinking creatively while ensuring transparency and clear decision-making.


More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Pharmaceutical
Region United States
Keywords Regulatory Affairs, Director

Contact information

Name Jennifer Wagner