Director, Regulatory Affairs

Deciphera Pharmaceuticals Inc.; Waltham (MA); Vor Ort; USD 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus

Medical insurance

401(k) match

Parental leave

Zusammenfassung

Deciphera Pharmaceuticals Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategies for oncology programs from early development through post-marketing.

The role provides expert guidance to cross-functional teams, drives regulatory submissions, and ensures compliance with global regulations. The ideal candidate will possess at least 12 years in regulatory affairs, with a proven track record submitting INDs and NDAs and interacting with FDA and other global agencies.

Qualifikationen

• BS or MS in a scientific discipline with at least 12 years in pharmaceutical Regulatory Affairs.
• Advanced knowledge of oncology drug development regulations in US and EU.
• Proven track record leading INDs, NDAs, and major regulatory filings.

Aufgaben

• Provide strategic regulatory leadership for assigned oncology programs from early development through post-marketing.
• Lead preparation and submission of INDs, NDAs, and other regulatory filings with cross-functional teams.
• Offer regulatory guidance to clinical, CMC, quality, and development teams to ensure alignment.
• Represent Regulatory Affairs in internal and external meetings with regulators.
• Mentor staff and manage resources to ensure timely milestone delivery.
• Drive process improvements to increase regulatory efficiency and innovation.

Kenntnisse

Regulatory strategy

Leadership

FDA interactions

Cross-functional collaboration

Regulatory submissions

Ausbildung

BS/MS in a scientific discipline

Jobbeschreibung

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. 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. Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com

The Director, Regulatory Affairs will join a group of highly motivated regulatory professionals and play a critical role in shaping cohesive regulatory strategies across Deciphera’s product pipeline.

The Director will operate as a strategic regulatory lead, developing and implementing global regulatory strategies for oncology programs from early development through post-marketing. This role will provide expert guidance to cross-functional teams, drive regulatory submissions, and ensure compliance with applicable regulations and industry standards.

Key Responsibilities

Regulatory Strategy & Leadership

• Regulatory lead for assigned oncology programs, developing and implementing innovative regulatory strategies from FIH through post-marketing stages.
• Provide regulatory input to clinical and development teams to ensure strategic alignment across functions.
• Monitor and interpret global regulatory trends and communicate potential impact on programs to senior leadership.

Regulatory Submissions & Compliance

• Lead the preparation and submission of INDs, NDAs, and other regulatory filings in collaboration with cross-functional teams.
• Ensure all submissions are of high quality, compliant, and meet global regulatory expectations.
• Provide hands-on operational oversight for submission preparation, review, and delivery.

Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Operations, Quality, and CMC teams to ensure regulatory strategy integration across all development activities.
• Provide timely and accurate regulatory advice to project teams and senior management.
• Represent Regulatory Affairs at internal and external meetings, including interactions with regulatory authorities.

Leadership & People Management

• Provide guidance and mentorship to Regulatory Affairs staff to enhance departmental capabilities.
• Assess team resources and project priorities to ensure timely delivery of key milestones.
• Promote a collaborative, solutions-oriented culture within the Regulatory Affairs organization.

Process Improvement & Innovation

• Contribute to continuous improvement initiatives and implement new processes to increase regulatory efficiency.
• Leverage learnings from prior projects to optimize global regulatory submissions and strategies.
• Foster innovation and strategic thinking in regulatory planning and execution.

Other duties and responsibilities as assigned

• B.S. or M.S. in a scientific discipline and a minimum of 12 years of experience in pharmaceutical Regulatory Affairs.
• Advanced knowledge and experience interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU.
• Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings.
• Experience engaging with FDA and other global regulatory agencies.
• Demonstrated ability to lead and manage multiple complex projects simultaneously.
• Excellent written, verbal, and interpersonal communication skills.

Preferred Capabilities

• Strategic thinker with the ability to anticipate regulatory challenges and propose innovative solutions.
• Experience working in oncology drug development at a small-to-midsize biotechnology company.
• Strong leadership and mentorship skills with a collaborative approach.
• Ability to thrive in a fast-paced, cross-functional environment.
• Detail-oriented, proactive, and results-driven mindset.

Deciphera believes in providing a fair, equitable, and 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.