Job DescriptionWe are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Manager 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 reports to the Executive Director, Head of Orexin Regulatory Strategy.
Responsibilities- Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed
- Support the development of submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, and develop risk mitigation strategies
- Support and 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 cross-functional teams
- Triage and coordinate responses to questions from regulatory authorities
- Support 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
- Support regulatory policy and intelligence activities, including commenting on guidance and monitoring the competitive and policy landscape for changes with potential impact
Qualifications- Bachelor's Degree in life sciences; advanced degree preferred
- At least 6-8 years' experience in the biopharma industry, preferably in neurology
- Experience with authoring regulatory information for IND and CTA documents
- Strong knowledge of FDA 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, strategic thinker with good attention to detail
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $134,000 - $149,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
