Associate Program Director, Commercial Regulatory Affairs (CORA)

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.

About the role

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.

Responsibilities

• Lead CMLRs and effectively collaborate with cross-functional groups and advertising agencies.
• Provide regulatory support to assigned products, business areas, and projects, offering sound regulatory guidance.
• Manage other departmental projects and deliverables, proactively identifying and addressing compliance issues.
• 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.
• Provide commercial regulatory affairs input into the cross-functional regulatory strategy for each product or portfolio assignment.
• Keep internal partners and stakeholders abreast of primary CMLR/CORA activities and status.
• Consult direct manager on all matters related to FDA communications, audits, and compliance violations.
• Participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products.
• Participate in special projects as assigned.

Qualifications

Competencies

• 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 their area. Quickly gains trust and respect from 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. Demonstrates good influencing and negotiation skills.
• Communication: 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.
• Organizational Skills: 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.

Education, Experience, and Knowledge

• Bachelor’s 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.

Pay

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.

Benefits

This position qualifies for the benefits detailed at the Genentech benefits link.