Full-Time Associate Director, Regulatory Affairs
Deciphera Pharmaceuticals is hiring a remote Full-Time Associate Director, Regulatory Affairs. The career level for this job opening is Manager and is accepting Waltham, MA based applicants remotely. Read complete job description before applying.
Deciphera Pharmaceuticals
Job Title
Associate Director, Regulatory Affairs
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Waltham, MA
Salary
YEAR $162200 - $223000
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Job Details
We are seeking an Associate Director, Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D, Clinical, Quality, and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways, risk assessment, and submission strategies.
Key Responsibilities
- Regulatory Strategy (50%)Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage. Provide solid regulatory solutions and guidance to the cross-functional teams and senior management. Provide tactical support and operational expertise with “hands on” support as needed.
- Project Management (25%)Assess project plans and timelines. Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time.
- Regulatory Compliance (25%)Ensure compliance of regulatory strategies and submissions. Oversee preparation and review of regulatory submissions and responses. Monitor regulatory trends and ensure proactive strategy adjustments. Other duties and responsibilities as assigned.
Required Qualifications
B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs 5+ years of regulatory experience working with global development and submission plans Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies
Preferred Experience
Capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent verbal and written communication skills Experience managing a regulatory team member
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Associate Director, Regulatory Affairs at Deciphera Pharmaceuticals is
13th of December 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Waltham, MA
] applicants. .
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