Associate Director, Regulatory Affairs CMC Writer

1 month ago

Boston, United States Pharvaris Full time

Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you


We are now looking to add capabilities to our regulatory team, considering ongoing and upcoming filings in Europe and the United States, and seeking to therefore hire an Associate Director Regulatory Affairs CMC Writer, to join our Regulatory Affairs team and report into our Director, Regulatory Affairs CMC.


This role will work collaboratively with the Regulatory, R&D and Technical Operations teams on writing projects for early and late-stage development programs. The selected candidate will be tasked with drafting, reviewing and finalizing CMC content and modules for INDs and CTAs, and later, should our clinical trials be successful will also help prepare NDA and MAA related content for the FDA, EMA and other regulatory bodies as needed.


Location

This role is based in Switzerland or the United States (East Coast). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.


Responsibilities

  • Develop balanced risk-based global regulatory CMC strategies for investigational assets in close partnership with the Director, Regulatory Affairs CMC. Proactively contribute to and influence product development and life-cycle management
  • Author CMC sections for filing and maintenance of INDs, CTAs, IMPDs, NDAs and MAA submissions as well as CMC source documentation for our clinical programs
  • Collaborate with Regulatory colleagues to execute CMC submissions and authoring strategy for assigned projects
  • Coordinate to life cycle mgmt.. (i.e.: variations) on a global scale, once clinical assets become commercial products
  • Proactively plan and manage writing activities across assigned projects as needed, ensuring adherence to the technical writing strategy and alignment with regulatory & health authorities’ requirements
  • Ensure consistency across all communications including all technical documents
  • Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams and as a deputy to the Director, Regulatory Affairs CMC in various internal and external meetings – representing Regulatory CMC as needed
  • Adhere to generally accepted writing standards to support CMC documentation
  • Create and maintain core documentation dossiers utilizing internal templates and tools
  • Participate in cross-functional team projects
  • Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed


Requirements

  • Bachelor’s degree in Life Sciences required; advanced degree such as MS, PharmD or PhD preferred
  • 8+ years of experience within Regulatory CMC in a pharmaceutical or biotechnology setting
  • Prior experience with FDA related submissions is required, prior experience with EMA and local market submissions is a plus
  • Regulatory CMC writing experience for small molecules and/or rare diseases is a plus
  • Demonstrated expertise in developing CMC content in Briefing documents, quality amendments, module 2 and 3 updates as well as CMC source documents in support of US and global regulatory submissions
  • Excellent IT skills including MS Excel, as well as authoring technologies and document mgmt. systems
  • Experience with eCTD is a plus, understanding of general electronic submissions guidelines is a must
  • Experience with StartingPoint templates is a plus
  • Highly effective communication and collaboration skills (verbal and written), excellent analytical skills and attention to detail
  • Ability to manage several priorities & work independently while optimally delivering results
  • Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results

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