Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
Position Summary:Commercial Regulatory Affairs (CORA) is part 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 our client's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry.
The CORA Department reports into the Head of U.S. Regulatory Affairs and is focused on the U.S. Market. Program Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.
Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction. Like Program Directors, Senior Program Directors will coordinate assigned deliverables and guide these when working with other team members, including within and outside of CORA.
Position Scope:Senior Program Director (E5A) is the specialist individual contributor position for CORA Review. Incumbents in this position:
- Lead Program Review Committees (PRCs) independently
- Assume responsibility for leading significantly complex product launches, combination product PRCs, departmental programs, projects and other deliverables with limited direction
- Demonstrate mastery of the review committee process and regulatory technical knowledge
- May serve as a subject matter expert (SME) for CORA with other departments
- Can effectively lead complex department projects (organizational design, long-range budget, capacity planning, organizational effectiveness, employee engagement, CORA strategy, vision, strategic objectives, etc.)
- Require limited direction to complete standard and non-standard work
- Are relied upon for sound regulatory guidance and apply a strategic approach to problem-solving
- Effectively integrate regulatory, legal and commercial context and business knowledge to address significantly complex problems
- Keep current in the areas of regulatory, healthcare compliance and ethics
- Proactively identify and address compliance issues
- Regularly lead cross-functional interactions, projects and teams
- Represent CORA on cross-functional review/decision-making committees of significant impact across the
- organization
- Typically operate with a planning horizon of 12 -18 months
Example Duties and Responsibilities:PRC Leadership:
- Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area. Typically assigned PRC responsibilities for complex products or business areas
- Serve as Functional Leader for CORA with internal partner groups, developing plans to strengthen PRC and other key regulatory review processes
- Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Foodand Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc.
- Represent the client in official FDA communications and sign-off on 2253s
- Act as a primary Roche liaison to the FDA on relevant CORA activities
- Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for their products
- Obtain and apply in-depth knowledge of Roche and regulatory guidelines, policies, procedures and best practices
- Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues.
- Communicate significant changes or other relevant matters to internal partners and stakeholders
- Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives
- 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 concepts and draft materials
- Develop and implement effective strategies for FDA marketing, advertising and communications submissions
- Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments
- Oversee and guide follow-on correspondence, such as resubmissions
- Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development
- Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations
- Provide oversight and decision-making leadership to junior CORA staff as well as day-to-day guidance to other CORA team members supporting the same PRCs or other assignments
- Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status
- Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations
Other:- As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant
- products
- As appropriate, represent CORA cross-functionally and support effective and efficient cross-functional
- coordination, appropriate resources, and timely, thorough and compliant execution
- Coach and mentor new or less experienced CORA staff members. Be viewed and respected as a leader
- within CORA
- Lead other special projects, as and when assigned, or otherwise requested