Senior Manager, Regulatory Project Management and Operations
Senior Manager, Regulatory Project Management and Operations
The Senior Manager of Regulatory Project Management and Operations is responsible for leading the planning, coordination, and delivery of high-quality regulatory submissions to global health authorities. This role ensures submission readiness, operational excellence, and compliance across cross-functional teams. The ideal candidate has strong project management capabilities, extensive experience with eCTD submissions, and the ability to navigate complex regulatory requirements in a fast-paced environment. This role will be based at our Waltham, MA site in the Boston metro area, with flexible on-site work arrangements.
Responsibilities
Regulatory Submission Strategy & Planning
- Lead end-to-end submission planning for investigational and marketing applications.
- Assess submission risks and develop mitigation plans to ensure on-time delivery.
- Partner with Regulatory Lead to define submission strategy, timelines, and deliverables.
Submission Management & Execution
- Manage content planning, authoring assignments, and cross-functional review cycles.
- Oversee the compilation, formatting, and publishing of regulatory documents in compliance with global eCTD requirements.
Cross-Functional Collaboration
- Act as the operational hub for regulatory submissions, facilitating communication across Regulatory, Clinical, Nonclinical, CMC, Program Management, and other functional teams.
- Drive submission team meetings, track progress, and mitigate risks.
- Establish clear roles, responsibilities, and timelines for team members.
Vendor & Outsourcing Management
- Manage interactions with external partners to ensure high-quality, timely filing.
- Evaluate vendor performance and implement process improvements as needed.
Requirements, Education, Experience & Skills:
- Bachelor’s degree in a scientific discipline
- 7+ years of regulatory submissions experience within the biotechnology or pharmaceutical industry.
- Proven track record managing major submissions (e.g., IND/CTA, NDA/BLA/MAA).
- Strong project management skills, with the ability to lead complex, cross-functional workstreams.
- In-depth knowledge of eCTD structure, global submission requirements, and electronic publishing systems.
- Strong project management skills, with the ability to lead complex, cross-functional workstreams.
- Excellent communication, organization, and attention to detail.
Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Senior Manager, Regulatory Project Management and Operations is $130,000-$200,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.
About Skyhawk
Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.
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