New · posted Oct 28
Genentech · Biotechnology
Associate Program Director, Commercial Regulatory Affairs (CORA)
- South San Francisco, CA
- On-site
- Full-time
- Director
The role
- Lead CMLRs and effectively collaborate with cross-functional groups and advertising agencies.
- Provide regulatory support to assigned products, business areas, and projects, providing sound regulatory guidance.
- Manage other departmental projects and deliverables, proactively identifying and addressing compliance issues.
- Effectively integrate regulatory risk/context and business knowledge while staying current in regulatory, healthcare compliance, and ethics.
- Monitor CMLRs and provide management oversight for scenarios such as FDA communications, audits, and compliance violations.
- Collaborate with commercial leadership to influence marketing strategies and facilitate the timely development and approval of promotional materials.
- Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies
- Provide regulatory input on commercial concepts and draft materials
- Support correspondence with the FDA and interpretation of FDA comments. Including follow-on correspondence, such as resubmissions
- Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development
- As appropriate, provide commercial regulatory affairs input into the cross-functional regulatory strategy for each product or portfolio assignment
- Keep internal partners and stakeholders abreast on primary CMLR/CORA activities and status
- Consult direct manager on all matters related to FDA communications, audits, and compliance violations
- As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products
- As assigned, participate in special projects
Commercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Division. The CORA Group reports into the Head of GPAL in the Global Legal Pharma Department.
Associate Program Directors of Commercial Medical Legal Regulatory Review Committees (CMLRs) provide regulatory support for assigned products or cross-portfolio activities and can lead cross-functional CMLRs with oversight from CORA Program Directors and their managers. They are experienced individual contributors expected to perform responsibilities with increased independence.
What you need
Requirements: Education, Experience, and Knowledge
- Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
- Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)
- 5 or more years’ work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry.
- Previous experience in regulatory and/or commercial regulatory disciplines preferred
- Must demonstrate working knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as working knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
Successful candidates will demonstrate the following competencies critical to this position:
- Decision Making. Gather information necessary to make decisions. Thinks through problems clearly and logically. Is decisive; doesn’t procrastinate on decisions. Expresses regulatory position and rationale, fluently and eloquently. Escalates issues in a timely and productive manner that eliminates churn and drives toward clarity.
- Technical and Business Expertise. Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area. Quickly gains trust and respect from his/her customers. Understands the perspectives of different functional areas in the organization.
- Teamwork and Collaboration. Addresses and resolves conflict by creating an atmosphere of openness and trust. Establishes strong collaborative relationships. Inspires others to do their best work by offering support and encouragement. Effectively facilitates and leads cross-functional discussions.
- Good influencing and negotiation skills. Demonstrates ability to lead diverse teams and influence stakeholders of varying organizational levels without direct authority
- Good verbal and written business communication skills. Can be relied upon to communicate in a consistently effective and professional manner. With limited management oversight, prepares well-researched and properly-toned emails in response to policy questions
- Good time management and organizational skills. Consistently meets deadlines without compromise to quality of work
- Strong attention-to-detail, as demonstrated through consistent quality of work
- Demonstrates process-orientation. Thinks through required steps and sequencing to ensure quality work output
- Demonstrates ability to identify appropriate resources
Skills named in this posting
Pay
$120,200 – $223,200 a year
Employer providedIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Where you'll work
South San Francisco, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAWorking conditions
Location
This role is located at Roche’s Genentech campus in South San Francisco, California.
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location of California is $120,200 to $223,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Equal opportunity, accessibility and legal noticesGenentech's statements, word for word
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
Job intelligence
The context around this role
Live data · October 29, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in California13 roles publishing pay
Director roles in the US37 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,200 | — | $223,200 |
| California (middle half) | $205,500 | $205,500 | $230,000 |
| All US (middle half) | $198,500 | $205,500 | $218,500 |
This role: Genentech's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 82 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Genentech's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- GMP and compliance7
- Regulatory submissions3
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Genentech on Regulatory Jobs
- 22
- Open roles
- 21
- Distinct roles
- 5
- Locations
By discipline
- Quality14 64%
- Compliance & Safety5 23%
- Regulatory3 14%
By level
- Senior & Principal17 77%
- Director3 14%
- Manager1 5%
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Associate Program Director, Commercial Regulatory Affairs (CORA) at Genentech
Open until filled. $120K–$223K a year, employer provided.