As a member of ONO Group
Manager, Regulatory Affairs
Location
Massachusetts
Posted
8 days ago
Salary
$116K - $160K / year
Seniority
Senior
Job Description
Manager, Regulatory Affairs
Deciphera Pharmaceuticals
• Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures. • Assist in coordination and preparation of global health authority meeting documents. • Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards. • Represents regulatory for global study-level regulatory activities included but not limited to study start-up, study maintenance, and end of trial activities. • Collaborate with external partners and vendors on regulatory activities and submission support. • Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance.
Job Requirements
- Bachelor’s degree, preferably in a scientific discipline.
- 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs.
- Strong knowledge of U.S. and international regulatory requirements for drug development.
- Excellent verbal and written communication, organizational, and cross-functional collaboration skills.
- Strong experience in a self-motivated, fast-paced environment.
- Experience supporting initial INDs/CTAs, and initial marketing application activities is highly desirable.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
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