Senior Regulatory Strategy Lead: Global Submissions

Alkermes; Waltham (MA); Hybrid; USD 134,000 - 149,000; Full time

Benefits offered by this job

Hybrid work model

Office in Waltham, MA

Competitive benefits package

Job summary

Alkermes is seeking a Senior Manager of Regulatory Affairs in Waltham, MA to guide new products into the clinic and support registration. The role provides strategic and tactical advisory to cross-functional teams while ensuring compliance with regulatory requirements across global programs.

The position reports to the Executive Director, Head of Orexin Regulatory Strategy and requires strong regulatory writing, FDA/ICH knowledge, and project management.

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; ability to explain complex issues clearly.
• Strong team player and situational leader; able to manage multiple priorities.

Responsibilities

• Contribute to development of global regulatory strategies for assigned projects; adapt and maintain the regulatory strategy as needed.
• Support submission plans and timelines; lead cross-functional efforts to deliver high-quality submissions and mitigate risks.
• Coordinate submission development, authoring content; direct SMEs in content development and ensure data-driven regulatory approach.
• Provide ongoing guidance to cross-functional teams; triage and coordinate responses to questions from regulators.
• Support interactions with Health Authorities; interpret feedback and communicate outcomes to the organization.
• Share best practices across the Regulatory Affairs organization; monitor policy landscape for changes with potential impact.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory writing

IND/CTA submissions

FDA & ICH guidelines

Project management

Education

Bachelor's Degree in life sciences

Advanced degree preferred

Job description

Alkermes is seeking a Senior Manager of Regulatory Affairs in Waltham, MA to guide new products into the clinic and support registration. The role provides strategic and tactical advisory to cross-functional teams while ensuring compliance with regulatory requirements across global programs.

The position reports to the Executive Director, Head of Orexin Regulatory Strategy and requires strong regulatory writing, FDA/ICH knowledge, and project management.