Associate Program Director, Commercial Regulatory Affairs (CORA)

Genentech; South San Francisco (CA); On-site; USD 120,000 - 223,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Genentech, located in South San Francisco, CA, seeks an Associate Program Director for Commercial Medical Legal Regulatory Review to lead cross-functional CMLRs and provide regulatory guidance across products and campaigns. The role requires directing regulatory strategy, ensuring compliance with FDA and Roche policies, and collaborating with commercial leaders on promotional materials.

The candidate should bring 5+ years in bio/pharma regulatory roles, with advanced degrees preferred, and

Qualifications

• Bachelor's degree in life sciences, law, public policy, marketing, business, education or related field is preferred.
• Graduate-level degree (JD, MBA, MS, PharmD or similar) strongly preferred.
• Minimum 5 years of experience in regulatory, legal, compliance, policy or related disciplines in bio/pharma.
• Experience in regulatory/commercial regulatory disciplines preferred.
• Working knowledge of bio/pharma regulatory environment and healthcare compliance.

Responsibilities

• Lead CMLRs and collaborate with cross-functional groups and advertising agencies.
• Provide regulatory support and guidance for products, business areas and projects.
• Manage departmental projects and address compliance issues proactively.
• Stay current in regulatory, healthcare compliance and ethics.
• Monitor CMLRs and provide management oversight for FDA communications, audits and compliance issues.
• Collaborate with commercial leadership to influence marketing strategies and approvals for promotional materials.
• Interpret FDA regulations and Roche policies for disease state and promotional materials.
• Provide regulatory input on commercial concepts and draft materials.
• Support FDA correspondence and follow-on submissions; represent CORA for CDS and US label development.

Skills

Decision making

Regulatory expertise

Cross-functional collaboration

Influencing & negotiation

Regulatory communication

Time management

Attention to detail

Process orientation

Resource identification

Education

Bachelor's degree

Graduate-level degree preferred

Job description

The Position

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.

The Opportunity

• 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

Who You Are

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.

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.).

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.

Benefits

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.

If 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.