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Director, Regulatory Affairs

Cambridge, MA 02139

Posted: 07/15/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2385

With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, our Client is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic decision making to inform, motivate, and energize internal and external stakeholders.

Reporting to the Senior Vice President, Regulatory Affairs and Quality, you will lead the Regulatory strategy and initiatives for the pulmonary therapeutic area. By joining a growing and dynamic regulatory affairs team, you’ ll be responsible for the preparation and maintenance of INDs and clinical trial applications that are compliant with US, foreign regulatory requirements, and company standards. You will provide regulatory guidance and oversight and improve internal standards and systems.

RESPONSIBILITIES:
  • Act as the primary regulatory representative on and provide strategic regulatory guidance to project teams and sub-teams
  • Lead the planning and preparation of global regulatory global submissions (eg, INDs, CTAs, IND safety reports, meeting requests)
  • Establish and manage regulatory timelines
  • Serve as the liaison between the company and regulatory agencies for assigned projects
  • Prepare meeting requests and briefing documents; assure team is ready for meetings/ teleconferences with regulatory agencies
  • Prepare regulatory development plans for assigned projects
  • Develop and maintain regulatory knowledge of US, EU and ROW regulations
  • Coordinate and prepare responses in response to Regulatory Agency requests
  • Perform literature searches, prepare special reports and assemble documentation to support project teams
  • Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
  • Maintain active INDs/CTAs (amendments and annual reports)
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participate in initiatives aimed at improving internal departmental standards and systems

REQUIREMENTS / QUALIFICATIONS:
  • Minimum of 8 years’ experience in a biotech and/or pharmaceutical environment, including 4-5 years in Regulatory Affairs
  • Minimum requirement of a Bachelor’ s Degree in a scientific discipline or equivalent
  • Experience working with biologics
  • Experience in multiple therapeutic areas preferred
  • Experience in orphan drug development a plus
  • You must be a team player that can handle multiple tasks simultaneously in a fast-paced company
  • Possess outstanding verbal and written communication skills
  • Requires a highly motivated, resourceful, creative individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
  • Excellent organizational skills and attention to detail
  • Experience with bio-pharmaceuticals is desirable

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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