Manager, Regulatory Affairs

Job overview

The Manager, Regulatory Affairs role is listed in Waltham, MA; the posting does not specify whether the arrangement is onsite, hybrid, or remote. The annual base salary range is $116,000–$160,000. Deciphera Pharmaceuticals is seeking regulatory support for global drug-development programs. The manager supports regulatory strategy and execution across development and lifecycle activities, helping prepare high-quality submissions and coordinate interactions with global health authorities. The role works across functions and with external partners to meet regulatory requirements and submission quality standards.

What you'll do

• Support preparation, review, and submission of INDs, CTAs, amendments, information requisitions, orphan drug applications, annual reports, and investigator brochures
• coordinate global health authority meeting documents
• contribute to regulatory strategy
• represent regulatory on study-level activities
• collaborate with external partners and vendors
• support regulatory operations and continuous improvement, including work instructions and SOPs.

What we're looking for

Skills & competencies

manager regulatory affairs

waltham ma

deciphera pharmaceuticals

drug development

regulatory submissions

ind

cta

health authorities

pharmaceutical industry

$116k–$160k

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual performance bonus
• medical, dental, and vision insurance
• 401(k) with company match
• parental leave and family planning benefits
• other incentive compensation plans where applicable.

Why this role

Requires a bachelor’s degree, preferably in a scientific discipline, and 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs.

About the employer

Deciphera Pharmaceuticals is hiring for this role. Industry: Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors. Sector: 92.