Director/Senior Director, Regulatory Affairs
United States
Regulatory Affairs /
Full time /
Remote
About Prilenia
Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a (Senior) Director Regulatory Affairs to join its team in the US.
We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.
Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases.
About the role
We seek an experienced professional to join our team as Regulatory Affairs Director. This position will lead the preparation for regulatory submissions to FDA, Health Canada, CHMP and various countries and manage other regulatory submissions/projects such as FDA meetings packages, scientific advice, orphan designations, clinical trial applications, IND amendments, etc. Major focus will be on North America, but given small team acting as back-up for EU and other countries is needed.
The ideal candidate will have comprehensive global knowledge and operational expertise for late stage development products. We are looking for Experience with NDA/MAA submissions in neurology and/or rare diseases, answering questions and leading to approval and first launch and and ability to implement this knowledge into regulatory strategy and practice.
The position will report to the Chief Regulatory and Commercialization Officer.
*Job level will be determined based on the candidate’s experience.
Roles and Responsibilities
- Lead the preparation for NDA/for US and Canada and support MAA submissions for pridopidine including:
- Coordinate the preparation and contribute to writing (and review) of other regulatory documentation (e.g. scientific advice requests, briefing documents, answers to questions, pediatric plans etc).
- Support regulatory activities to start global phase 3 in ALS.
- Maintain INDs.
- Support maintaining core labeling document and implementation in local labeling.
- Ensure maintenance and compliance of regulatory activities (like DSURs, PSURs; PIP annual update), including archiving and tracking in databases and systems, and support inspection readiness.
- Work closely with the Chief Regulatory and Commercialization Officer to implement regulatory strategy and provide regulatory expertise for various company projects.
- Follow regulatory intelligence updates and competitor’s status, and assess potential impact on daily activities and project strategy.
o Driving the timeline of preparation with all internal and external stakeholders.
o Authoring and reviewing key modules and sections.
o Conducting gap analyses (with external experts if needed) and ensuring timely submission readiness.
o Overseeing work by external regulatory vendors (including publishing, regulatory writing teams).
o Coordinate and prepare for regulatory meetings, scientific advice and/or interactions with agencies in support of NDA/MAA filings.
Qualifications
- Bachelor’s degree in Life Sciences.
- RAC certification - preferred.
- Minimum of 8+ years of relevant work experience in Biotech/Pharma Regulatory Affairs with proven track record of successful support of major submissions and dossiers (including NDA/BLA/MAA).
- Demonstrated experience in global / US / European Regulatory Affairs with products under development and/or marketed products (in rare diseases / neurology – preferred).
- Demonstrated experience in communicating effectively and meeting with Regulatory Agencies.
- Proven track record of managing complex projects from initiation to completion in a timely manner.
- Proven ability to work effectively in remote setting.
Skills
- A planner and influencer that can effectively drive submission projects (big and small) to timely execution at the highest quality.
- An excellent writer with ability to produce crisp written and oral regulatory/scientific documents with clarity and accuracy.
- Have exceptional attention to detail (you can spot discrepancies and errors no matter how small they are).
- Independent and excellent at proactively resolving complex issues independently, result driven with a sense of responsibility, purpose, and urgency, and able to perform and multi-task under pressure.
- Demonstrated ability for creativity and “out of the box” thinking that makes Regulatory a business partner.
- You are efficient and effective working remotely and independently with stakeholders/ manager located in other countries.
Location/Time Zones
- This is a full-time remote position in the East Coast of United States (preference for Boston area), with occasional in-person meetings.
- Flexible schedule with interactions across Israel, North America and Europe time zones.
