Associate Program Director, Commercial Regulatory Affairs (CORA)

Genentech•Daly City, CA

8d•$120,200 - $223,200•Onsite

About 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.

Requirements

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.
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.)

Nice To Haves

Previous experience in regulatory and/or commercial regulatory disciplines preferred

Responsibilities

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.