• Job Description

  Req#: 13377

  We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D.

  This role is based in our Waltham, MA facility and reports to the Vice President, Head of Regulatory Strategy. It is eligible for hybrid in the office 3 days/week.

  Qualifications

  • Degree in life sciences; advanced degree preferred
  • At least 6-10 years’ experience in the biopharma industry, preferably in neurology
  • Experience as primary regulatory author for IND and CTA documents
  • Strong knowledge of FDA, EMA, and ICH regulatory guidelines and eCTD structure
  • Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely
  • Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals; able to be a situational leader when required
  • Highly skilled at project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk
  • Able to work independently on competing priorities in a fast-paced and dynamic environment; a creative thinker with good attention to detail

  Responsibilities

  • Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed
  • Develop submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, and develop risk mitigation strategies
  • Coordinate submission development, developing and authoring content as applicable. Direct subject matter experts in content development and authoring. Ensure documents take a data-driven regulatory approach
  • Provide ongoing guidance to project teams
  • Triage and coordinate responses to questions from regulatory authorities
  • Participate in interactions with Health Authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization.
  • Share best practices across the broader Regulatory Affairs organization
  • Manage regulatory policy and intelligence activities, including commenting on guidance and monitoring the competitive and policy landscape for changes with potential impact

• About the company

  Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

Notice