New · posted Nov 11
Exelixis · Biotechnology
Sr Regulatory Operations Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
SUMMARY/JOB PURPOSE
Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs. Provide eCTD technical expertise and manage submission plans in Veeva RIM to ensure timely, high-quality submissions that meet Health Authority requirements and company standards. Implement evolving FDA requirements and collaborate on process, technology and automation improvements to enhance efficiency, compliance and scalability.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
- Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
- Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
- Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
- Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
- Create regulatory submission objectives, submission content plans, and documentation within Veeva RIM.
- Routinely participate in the review of evolving FDA electronic submission requirements and technical standards, assess operational impact and implement changes as appropriate.
- Collaborate within Regulatory Operations on SOPs, work instructions, templates, checklists, standards and best practices that support consistent and efficient Regulatory Operations processes.
- Performs other duties as assigned
- Complies with all policies and standards
What you need
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES Education
- Bachelor’s degree in related discipline and a minimum of nine years of related experience; or,
- Master’s degree in related discipline and a minimum of seven years of related experience; or,
- PhD degree in related discipline and a minimum of two years of related experience; or,
- Equivalent combination of education and experience.
Knowledge, Skills and Abilities Required
- Subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools.
- Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
- Applies knowledge of the regulatory framework and industry practices to complete routine work.
- Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to small groups of departmental colleagues.
- Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.
- Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.
- Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
- Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Travel Requirements
- 20% Travel approximately 20%
Location: Remote Range for this position: $165,000 - $208,500 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].
What you'll do
SUPERVISORY RESPONSIBILITIES
- None.
Pay and benefits
$165,000 – $208,500 a year
Employer provided401k with company contributions
Medical, dental and vision coverage
Life and disability insurance
Discretionary annual bonus
Company stock purchase opportunity
15 vacation days and 17 paid holidays
Working conditions
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
Equal opportunity, accessibility and legal noticesExelixis's statements, word for word
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.
Exelixis is an E-Verify employer.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Manager roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $165,000 | — | $208,500 |
| All US (middle half) | $161,750 | $176,000 | $189,500 |
This role: Exelixis's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 42 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Exelixis's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Documentation and SOPs6
- Collaboration and leadership5
- Data and digital systems4
- GMP and compliance3
- Validation and qualification3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissionsNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLA
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- 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
- 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)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Exelixis on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 2
- Locations
By discipline
- Clinical12 60%
- Regulatory4 20%
- Quality4 20%
By level
- Director14 70%
- Manager3 15%
- VP & Executive1 5%
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Sr Regulatory Operations Manager at Exelixis
Open until filled. $165K–$209K a year, employer provided.