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Director, Regulatory Affairs

Boston, MA

Posted: 10/07/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2443

Reporting to the Vice President, Regulatory Affairs, you will lead the regulatory strategy and initiatives for your assigned programs. By joining our client’ s growing and dynamic regulatory affairs team, you’ ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide regulatory guidance and oversight and improve internal standards and systems. Key accountabilities include providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of client’ s products.

Responsibilities
  • Act as the primary regulatory representative on multi-disciplinary project teams and provide strategic regulatory guidance on development plans
  • Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines
  • Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments
  • Lead or assist in the planning and preparation of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests
  • Prepare meeting requests and briefing documents; assure team is ready for meetings and teleconferences with Regulatory Agencies
  • May serve as the liaison between the company and Regulatory Agencies for assigned projects
  • Develop and maintain knowledge of US, EU and ROW regulations as appropriate for the assigned program(s)
  • Help keep cross-functional team members apprised of new regulations, standards, policies, and guidance issued by Regulatory Agencies that may impact the company
  • Perform literature searches, prepare reports and assemble documentation to support project teams as required
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participate in initiatives aimed at improving internal standards and systems
  • May participate in evaluation of advertising and promotional materials for commercial products

Requirements/Qualifications
  • B.S. or graduate degree in life sciences
  • At least 12 years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development both big and small company experience is preferred.
  • Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, breakthrough therapies, PRIME)
  • Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
  • Full functional knowledge of regulatory requirements (regulations, directives, and guidances/guidelines) pertaining to the development and registration of drug products in multiple ICH regions
  • Ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and react to new information or changing priorities
  • Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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