Director, Regulatory Affairs
uniQure is dedicated to bring 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 life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
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.
Key result areas (major duties, accountabilities and responsibilities)
- Lead, develop and implement regulatory strategy in order to meet corporate goals and objectives.
- Provide regulatory oversight and guidance to project teams on compliance matters, FDA and other competent authority requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
- Lead and participate in the planning, preparation and delivery of submissions throughout the product’s life cycle including briefing documents, INDs, CTAs and annual reports.
- Lead the planning, strategy, content and execution of BLA and MAA filing and approval.
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risk.
- Prepare the team and lead negotiations with FDA, EMA and other health agencies.
- Provide regulatory due diligence as required.
- Responsible for preparation/submission/maintenance of future MAA, BLA and IND/IMPD (including variations and amendments), Scientific Advice and FDA meetings for all of uniQure’s pipeline products and support activities.
- Advise CMC, Clinical and non-clinical functions (Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of IMPDs, INDs, BLA 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.
- Development of promotional, advertising, and labeling items.
- Represent the Company at meetings with Regulatory Authorities.
- Liaising closely with uniQure’s commercialization partners to support product development and licensure.
- Follow new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline.
- Providing counsel, training, and interpretation of FDA, EMA and other regulatory issues to Company personnel and assisting as a liaison between the Company and Regulatory Authorities.
- 8-10+ years of Regulatory Affairs or related experience, Master or a higher scientific degree (PharmD, PhD).
- 8-10+ years’ experience in therapeutic products (preferably biologics/vaccines/advanced therapeutics).
- 8-10+ 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, EMA and CDER requirements for the drug approval process.
- Previous participation in preparing Regulatory submissions (IND, CTA, BLA, MAA 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
- Experience with biotechnology derived products (RNA, mAbs, proteins), viral vaccines; viral vectors and gene therapy are a plus.
- 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.
- 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.
- Demonstrated people management experience, and development/growth and retention of talented personnel, differentiating performance and rewarding accordingly.
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Job posted: 2020-09-21