Associate Director/Director Regulatory Affairs

East Coast, US

Position Summary:

We are looking for a Regulatory Director to lead the preparation for NDA and MAA submissions and manage other regulatory projects. 

  • Have comprehensive knowledge and operational expertise of EU and US regulations (including NDA/MAA submissions) and ability to implement this knowledge into regulatory strategy and practice

  • Are a planner and influencer that can effectively drive submission projects (big and small) to timely execution at the highest quality 

  • Are 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)

  • You 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 goes beyond Regulatory being a pure “gate keeper” 

  • You are efficient and effective working remotely and independently with stakeholders/ manager located in other countries

Professional qualifications:

  • Bachelor’s degree in Life Sciences

  • Minimum of 5+ 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)

  • Demonstrating experience in communicating effectively and meeting with Regulatory Agencies

  • Proven track record of managing complex projects from initiation to completion in a timely manner
     

Roles and Responsibilities:

  • Lead the preparation for NDA and MAA submissions for pridopidine in preparation for pivotal trial results in 2022/2023 including:

       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

  • Coordinate the preparation and contribute to writing (and review) of other regulatory documentation (e.g. scientific advice requests, briefing documents, pediatric plans etc).

  • 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.

If you wish to apply for this position, please email your CV to