Director - CMC Regulatory Affairs (m/f/d)
|Date posted:||22. May 2023|
|Location:||Vienna, New York|
The Regulatory Affairs Director is a creative, resourceful, integrative thinker that is responsible for key regulatory CMC activities supporting the development and commercialization of Hookipa's products, with a focus on developing and implementing regulatory strategies as well as coordinating and responding to questions from Health Authorities. Responsibilities will include development and implementation of CMC strategy from early development to post product approval, preparation, and review of CTD Module 3, QOS, and other documents for FDA/EMA submission, assistance with preparation for FDA meetings, regulatory review of cGMP documentation, and general regulatory compliance activities.
- Serve as the Regulatory Affairs (RA) CMC project representative to the Regulatory Development team, covering US, EU, and the rest of the world CMC regulatory requirements for regulatory submissions from early development to post-commercial maintenance of assigned products and dossiers
- Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; Health Authority responses & background packages (including participating/leading Health Authority meetings); &/or post-approval submissions.
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
- Manage regulatory submissions that involve CMC components including CBEs/PASs/ CTAs/INDs/NDAs and agency meeting packages
- Contribute to the preparation of meetings with regulatory agencies
- Support Health Authority interactions and negotiations including more complex interactions for all CMC topics for assigned Hookipa projects, settingobjectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
- Drive follow-up action plans resulting from agency feedback for assigned Hookipa projects.
- Participate in negotiations with regulatory agencies to resolve CMC and GMO issues
- Assist during regulatory agency inspections
- Actively participate in RA infrastructure and capability building
- Proactively support activities in design of global regulatory strategies for the development of therapeutic oncology and infectious disease products
- Available to travel (approximately 1 week per 2-4 months)
BS in life science related field required, MS/PhD preferred
- Oncology, Vaccine or Biologics experience preferred
- Minimum 6 years of experience in the pharmaceutical/biotechnology/life science industry . 4+ years regulatory affairs experience including regulatory CMC and/or GMO strategy for development and/or commercial pharmaceutical products required
- Experience with cell and gene therapy and vaccines are a plus
- Experience of working in a global, matrix environment (multidisciplinary international team).
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts within the company and with alliance partners
- Excellent written and oral English, communication skills, and attention to detail
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
- Understanding of electronic submissions
- Knowledge and understanding of US, EU, Canada, and ICH guidelines. Understanding of international GMO requirements is a plus
- Highly computer literate (MS Office suite, WebEx and secure file sharing…)
What we offer
- Strong and highly motivated team
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
- Employee benefits such as health screening, public transportation card, Sodexo passv (only for AT)
For Austria: We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 5.438, - based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
For US: We offer a comprehensive package with competitive salary in the range of USD 150-230k, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: firstname.lastname@example.org
|Starting date:||24. May 2023|