Director - Regulatory Affairs Strategy
|Date posted:||21. March 2022|
|Location:||New York, Vienna|
Regulatory Affairs Director is responsible for managing Regulatory Affairs activities (with a focus on nonclinical and clinical) for assigned investigational products, including working with the VP or Regulatory Project Lead on the development of overall regulatory strategies for development of investigational drugs and post-approval marketed product support. This individual is responsible for maintaining an in-depth awareness of relevant federal and international regulations and policies to optimize Hookipa’s regulatory strategic input to assigned project teams for investigational and marketed products.
- Formulate, lead and drive global regulatory strategy for Biologic projects/products drawing on extensive regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
- Works with the Vice President to lead regulatory activities, including planning and reviewing of nonclinical and clinical sections of regulatory submissions for format and content.
- Works with the Vice President to develop and manage regulatory submission project timelines for assigned projects.
- Works with the Vice President to prepare, review and file documents to health authorities, in particular investigational new drug applications (INDs) and/or marketing applications (NDAs/MAAs).
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Works with the Vice President to coordinate and prepare company responses to information requests from health authorities.
- Acts as the primary company contact to health authorities for assigned investigational drugs and marketed products, including leading meetings with health authorities and business partners.
- Initiate and lead Health Authority interactions and negotiations including more complex interactions; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA
- Reviews current policies and practices issued by Federal regulatory agencies and updates Hookipa management as needed.
- Contribute to the preparation of meetings with regulatory agencies
- 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 participate in design of global regulatory strategies for the development of therapeutic oncology and infectious disease products
- Must be eligible and available for international travel
- Bachelor’s degree in Chemistry or Biology or Pharmaceutical Science or related field required.
- Pharm. D., M.D., JD, or Master’s degree in Chemistry or Biology or Pharmaceutical Science or related field preferred.
- Minimum 6 years of experience in the pharmaceutical/biotechnology/life science industry. 4+ years regulatory affairs experience including regulatory IND filing and strategy for development and/or commercial pharmaceutical products required
- Required to have experience writing, building and filing IND’s
- Must have demonstrated experience IND/NDA annual reports in an e-CTD format.
- Oncology, Vaccine or Biologics experience preferred, but not required
- Extensive knowledge/experience in regulatory submission and approval processes and ability to solve complex regulatory issues and requirements
- Proven ability to critically evaluate data from a broad range of scientific subject areas
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects
- Excellent written and oral English, communication & presentation skills, and attention to detail
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
- Strong skills in planning, organizing, decision-making and problem-solving.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Strong interpersonal skills with the ability to interact effectively with all levels of personnel both within and outside the organization.
- Strong ability to prioritize tasks and keen attention to detail.
- Demonstrated ability to stay abreast of trends and new information in the profession.
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
Starting date: As soon as possible
We offer a comprehensive package with competitive salary, 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
Contact: If you (m/f) are interested in this challenging position, please send your CV including a cover letter summarizing your qualification and experiences to: talent(at)hookipapharma.com For more information on Hookipa Biotech please visit www.hookipapharma.com