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…