Director, Regulatory Affairs

Proteostasis Therapeutics   •  

Boston, MA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 113 days ago

Duties & Responsibilities:

  • Develop and implement regulatory strategies for all products in development.
  • Ensure efficient execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) worldwide
  • Lead activities, including planning, writing and reviewing, as well as responses to regulatory agencies, of all regulatory submissions (INDs, CTAs, meeting requests, and briefing documents) to supportclinical trials and project milestones.
  • Be responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.
  • Be responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities which has the potential to impact strategy
  • Have knowledge of current global regulations and guidelines
  • Review Clinical, Nonclinical, and CMC documentation to ensure compliance with regulatory requirements.
  • Work effectively on cross-functional teams and be the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies and external contract organizations.
  • Guide project teams in planning and requirements for future commercial filings (NDA/MAA) and assess regulatory impact for development process changes.
  • Monitor and effectively manage regulatory project timelines and budgets
  • Lead junior level regulatory employees
  • Other duties and ad hoc projects as assigned.

Qualifications:

  • 7-10 years of industry experience in pharmaceutical product development, with a minimum of 5 years in Regulatory Affairs.
  • Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
  • Experience in rare/orphan disease desirable
  • Combination product development experiencepreferred
  • Pediatric development experience is desirable
  • Excellent written and oral communication and interpersonal skills.
  • Solid knowledge of overall drug development and in-depth knowledge of FDA and EMA regulatory requirements.
  • Works well in a high-achieving team based environment.
  • Sense of urgency is a must.
  • Previous direct experience in leading development and/or marketing authorization submission teams and in interacting with regulatory authorities.