uniQure

Director, Regulatory Affairs (CMC) - 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):

  • Responsible for preparation/submission/maintenance of Module 3 of current and future MAA and IND/IMPD (including variations, amendments, annual reassessment) and Scientific Advice and FDA meetings related to CMC for all of uniQure’s pipeline products and support activities.
  • Advises all CMC related functions (Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of IMPDs, INDs and MAA dossiers to ensure timely delivery of final documents to be included in submissions.
  • Guide CMC stakeholders and project management on regulatory issues and impact assessment including CCRs and Deviations with the QA Team and maintain records of the decisions.
  • Responsible for the development and implementation of the Regulatory Compliance system and for developing the relevant procedures.
  • Oversight of up-to-date electronic database of documentation (e.g. up-to-date eCTD sections, IMPDs).
  • Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences.
  • Developmentof promotional, advertising, and labeling items as it pertains to CMC modules.
  • Representing the Company meetings with Regulatory Authorities.
  • Liaising closely with uniQure’s commercialization partners to support product development and licensure.
  • 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 EMA 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 Regulatory Authorities to represent and defend the company’s interests and the building of a regulatory network of competent partners.

 

Qualifications:

  • 8-10+ years of Regulatory Affairs or related experience, Bachelor or a higher scientific degree (MS, PharmD, PhD).
  • 5-10+ years’ experience in therapeutic products (preferably biologics/vaccines/advanced therapeutics).
  • 5-10+ regulatory experience in the biotech/pharmaceutical industry in both the pre-market and post-market setting.
  • Experienced in Regulatory Agency meetings resulting in successful outcomes.
  • Experience with global regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations.
  • Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD, and CDER requirements for the drug approval process.
  • Previous participation in preparing Regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities
  • Solid understanding of the e-CTD specifications for electronic submissions.
  • Experience working with and implementing electronic tools used for submissions a plus.
  • Strong technical writing ability and previous experience in documentation preparation/publishing using Adobe Acrobat, preferred
  • MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio

 

Core competencies:

  • Affinity with biotechnology derived products (RNA, mAbs, proteins), vaccines, viral vectors or gene therapy
  • Demonstrated people management experience, and development/growth and retention of talented personnel, differentiating performance and rewarding accordingly.
  • Excellent oral and written communication skills which would be 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 outside the box, 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 Director, Regulatory Affairs, CMC

Contact information

Name Jennifer Wagner

Location

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