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Sr. Manager/AD, Regulatory Affairs

Cambridge, MA

Posted: 04/16/2019 Employment Type: Contract Job Category: Clinical: Regulatory Job Number: 2330
The Sr. Manager/Associate Director of Regulatory Affairs provides regulatory leadership in support of development programs. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the regulatory affairs department.

The successful candidate will serve as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management. Title will be commensurate with incumbent’ s experience.

  • Develop and implement regulatory strategy
  • Represent the regulatory function on cross-functional development teams and with partner companies
  • Assesses and communicates regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines. This will entail keeping abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions.
  • Provide regulatory guidance and strategy including identification and assessment of regulatory risks
  • Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications and all related amendments (IND, CTA, NDA, and MAA)
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Work with Regulatory Operations to develop submissions in electronic format
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities, as appropriate. At Sr. Manager level work with Director on these activities
  • Working with cross-functional team, coordinate and prepare responses to requests for information from regulatory authorities
  • BA/BS in life science or health related field; advanced degree preferred
  • 8 years of Regulatory Affairs experience within the biotech or pharmaceutical industry; peptide experience a plus
  • Knowledge and understanding of global regulations and guidelines
  • Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
  • Experience with investigational, including late stage development, and/or marketed products
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective
  • Strong attention to detail and the ability to handle multiple tasks
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  • Strong interpersonal skills including verbal and written communication

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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