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Manager, Regulatory Affairs

Cambridge, MA

Posted: 11/01/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2431

Job Description

Reporting to the Director of Regulatory Affairs, the Manager of Regulatory Affairs  will provide strategic input and operational regulatory support to cross-functional teams responsible for development and registration of our client’ s pipeline candidates. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.

Responsibilities include:
  • Work cross-functionally with clinical, chemistry, manufacturing & controls (CMC), nonclinical, and pharmacovigilance to develop and execute regulatory strategy and submission plans for quality and timely filings
  • Act as regulatory lead for assigned program (s) and provide robust regulatory guidance regarding FDA and international (Canada, EU and Asia-Pacific) regulatory requirements for global clinical development and registration of oncology drugs
  • Author and review regulatory documents in compliance with regulatory requirements
  • Support regulatory interactions with FDA and international regulatory bodies including preparation of briefing documents
  • Manage and ensure compliance with all reporting requirements including annual and periodic reports
  • Provide strategic guidance for and author applications related to designations for expedited programs or special status
  • Represent the regulatory affairs function in project teams to provide regulatory support and advice
  • Identify and assess regulatory risks for assigned programs to develop and implement short and long-term regulatory strategies
  • Participate in regulatory intelligence efforts
  • Draft and/or modify applicable SOPs and/or written practices relating to the regulatory affairs function

Requirements / Qualifications:
  • Bachelor’ s degree, MS or advance degree a plus, Life/Health Sciences preferred
  • 3+ years regulatory drug development experience
  • Experience in late-phase drug development
  • Experience in rare disease or oncology drug development a plus
  • Experience with regulatory submission procedures and regulations, preparation and writing regulatory documentation to support agency interactions
  • Experience with IND / CTA / marketing applications
  • Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, and ROW regulatory requirements a plus
  • Strong project management skills including familiarity with PM toolkits
  • Ability to work both independently with minimal direction and within project teams to achieve department goals
  • Demonstrate excellent written and oral communication skills
  • Demonstrate strong organizational skills
  • Strong interpersonal skills and the ability to work effectively with a variety of disciplines including medical, scientific, and technical functions

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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