New · posted Nov 11
Deciphera Pharmaceuticals · Pharmaceuticals
Director, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
The role
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.
What you need
Preferred Capabilitiesnice to have
- 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)
What you'll do
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.
Pay and benefits
$196,000 – $245,000 a year
Employer providedCompetitive 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 opportunity, accessibility and legal noticesDeciphera Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in Massachusetts17 roles publishing pay
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $196,000 | — | $245,000 |
| Massachusetts (middle half) | $227,500 | $232,500 | $275,000 |
| All US (middle half) | $222,250 | $249,500 | $271,875 |
This role: Deciphera Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 91 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Deciphera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership16
- Regulatory submissions6
- GMP and compliance2
- Documentation and SOPs1
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Deciphera on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 2
- Locations
By discipline
- Clinical9 90%
- Regulatory1 10%
By level
- Director7 70%
- Manager3 30%
More roles at Deciphera
- View role
Senior Clinical Project Manager
Remote, USManagerPharmaceuticals$138K–$168K
- View role
Director, Clinical Operations
Remote, USDirectorBiotechnology$216K–$263K
- View role
Associate Director, Clinical Scientist
Remote, USDirectorBiotechnology$193K–$230K
- View role
Medical Director, Clinical Development (Neurology)
Remote, USDirectorBiotechnology$248K–$341K
Similar Regulatory Strategy roles elsewhere
- View role
Director, Regulatory Affairs, Precision Medicine Digital Health
GSKWaltham, MA · HybridDirectorPharmaceuticals$172K–$286K
- View role
Regulatory Affairs Director
AstraZenecaCambridge, MA · HybridDirectorPharmaceuticals$186K–$279K
- View role
Director, RA Global Regulatory Strategy
AbbVieCambridge, MA +1 moreDirectorPharmaceuticals$182K–$346K
Director, Regulatory Affairs at Deciphera
Open until filled. $196K–$245K a year, employer provided.