Global Regulatory Affairs Manager, Submissions & Strategy

Deciphera Pharmaceuticals; Waltham (MA); On-site; USD 116,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Parental leave and family planning

401(k) retirement plan

Job summary

Deciphera is seeking an experienced Regulatory Affairs Manager to support global regulatory activities across development programs and lifecycle management. You will partner with cross-functional teams to ensure high-quality regulatory submissions and successful interactions with health authorities.

The role involves contributions to global regulatory strategy, coordination of study start-up activities, and collaboration with external partners.

Qualifications

• Bachelor's degree in a scientific discipline.
• 6+ years in the pharmaceutical industry, including 4+ years in Regulatory Affairs.
• Strong knowledge of US and international regulatory requirements.
• Excellent verbal and written communication, organizational and collaboration skills.
• Experience supporting initial INDs/CTAs and initial marketing applications is desirable.

Responsibilities

• Support preparation, review and submission of regulatory filings including INDs/CTAs and amendments.
• Assist in coordination and preparation of global health authority meeting documents.
• Contribute to global regulatory strategy and ensure submissions meet requirements.
• Represent regulatory for study start-up, maintenance, and end of trial activities.
• Collaborate with external partners and vendors on regulatory activities.
• Support regulatory operations and SOP development and maintenance.

Skills

Regulatory affairs

Communication skills

Cross-functional collaboration

Regulatory submissions

IND/CTA experience

Education

Bachelor's degree in a scientific discipline

Job description

Deciphera is seeking an experienced Regulatory Affairs Manager to support global regulatory activities across development programs and lifecycle management. You will partner with cross-functional teams to ensure high-quality regulatory submissions and successful interactions with health authorities.

The role involves contributions to global regulatory strategy, coordination of study start-up activities, and collaboration with external partners.