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Director, Regulatory Affairs

Position Summary: 

We are seeking an experienced and highly motivated individual for the position of Director of Regulatory Affairs, reporting directly to the Head of Regulatory Affairs. The Director will provide global regulatory strategic and operational leadership to assigned programs, ensuring alignment with department and company strategy to facilitate timely drug development and global registrations. Strong leadership and communication (written and verbal) and collaboration skills, and excellent regulatory strategic thinking will be critical to the success of this position.

Essential Functions:

  • Lead multiple regulatory activities (nonclinical, clinical and in vitro diagnostic) to assure timelines and milestones are met to support the business needs of the company.
  • Devise and implement innovative global registration strategies and ensure cross functional alignment.
  • Develop regulatory strategies to reduce regulatory risks associated with clinical, nonclinical and CMC sections of an NDA/MAA; work with respective teams to implement them.
  • Serve as primary contact for global regulatory authorities for assigned projects.
  • Plan, execute and lead successful regulatory agency meetings and interactions per regulatory strategy.
  • Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future marketing applications (e.g. NDA and MAA).
  • Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions.
  • Provide regulatory expertise for development of product labels and core data sheets.
  • Serve as regulatory liaison with government partners, business partners and CROs.
  • Provide leadership on project teams in all areas of regulatory affairs.
  • Prepare and deliver effective presentations for external and internal audiences as needed.
  • Maintain knowledge and monitor changes in pertinent laws, regulations and guidances. Interpret external developments and inform/educate stakeholders.

Preferred Experience:

  • At least 10 years’ experience in Regulatory Affairs in the Pharmaceutical or Biotechnology industry.
  • Demonstrated leadership abilities including the ability to present and defend regulatory strategies and plans to the company’s senior leadership.
  • Proven track record in developing and implementing regulatory strategies in challenging environments (e.g. rare diseases).
  • Demonstrated ability to employ creative strategies to maximize team efficiency.
  • Experienced in submitting INDs, NDAs, and MAAs and in managing international regulatory filings.
  • Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products.
  • Well-developed critical reasoning skills.
  • Experience in the anti-infectives therapeutic area preferred but not essential.
  • Experience with the development of in vitro / companion diagnostics a plus.
  • Proven ability to collaborate across multiple functions and build effective relationships.
  • Demonstrated ability to work in a dynamic environment with a high degree of flexibility.
  • Excellent team interaction skills along with demonstrated ability to work in a cross functional team and influence the decisions of a team.

Preferred Education:

  • A minimum of a Bachelor’s degree in a scientific discipline required. A Master’s or Doctorate degree preferred.
  • RAC certification also preferred but not required.

Preferred Additional Skills:

  • Demonstrated excellence in independent management of complex projects.
  • Creative, outside-the-box thinking.
  • Strong written and verbal communication skills and presentation effectiveness.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Available for up to 10% travel domestically and internationally.
  • Current US work authorization required.
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