Manager, Regulatory Affairs

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, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK® (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability-empowering individuals to challenge the unknown together.

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

Job Description

We are seeking an experienced regulatory professional to support global regulatory activities across early- and late-stage development programs through lifecycle management. The Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities.

Key Responsibilities

• 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.

Qualifications

• 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.

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $116,000 - $160,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).

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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.