Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
Global Regulatory Affairs leader supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s). Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no Regulatory Affairs (RA) sub-team support as appropriate. Regulatory Strategy: ? Provide regulatory leadership to assigned project(s). ? Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans. ? Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy ? Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks. ? Responsible for development and implementation of the Regulatory Seed Document/Regulatory Functional Plan. ? Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally. ? Partner with regions to align on regulatory strategy in order to fulfill business objectives. ? Obtain timely consultation with RA line management and Novartis advisory boards on regulatory strategy. ? Lead interactions with regulatory consultants/advisors for strategic input and challenge. ? Represent RA on the GPTs and communicates key program information to regulatory team members and RA management. ? Provide strategic input to GPT and RA team on key HA documents, obtaining appropriate line endorsement as appropriate. ? Provide strategic input, review and approve clinical study protocols and protocol amendments ? Lead RA activities regarding Novartis safety risk communications for the assigned projects. ? Provide strategic regulatory input into BD&L Due Diligence evaluations as required. HA Interactions: ? Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate. ? Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy. ? May lead interaction with HAs during key HA meetings ? Provide leadership by supporting the Global Program Regulatory Managers in their direct interactions with HAs as appropriate. Submissions and Approvals: ? Lead the global submission planning process, including potential Advisory Committees. ? Lead regulatory submission process throughout project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Fluency in English as a business language. Additional language is an asset. ? Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas: ? Innovation in regulatory strategy. ? Prior history with post-marketing/brand optimization strategies and commercial awareness ? Major involvement in a CTD/MAA/NDA submission and approval. ? Leadership role in HA negotiations in multiple regions. ? Proven success in global drug regulatory submissions. ? Proven ability to analyze and interpret efficacy and safety data. ? Regulatory operational expertise. ? Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry. ? Global matrix management people management experience desirable. ? Good management, interpersonal, communication, negotiation and problem solving skills.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Internal Number: 248534BR
About Novartis Pharmaceuticals
The Pharmaceuticals Division of Novartis is recognized worldwide for the innovative medicines we provide to patients, physicians and healthcare organizations.
This growing business develops and markets patent-protected prescription drugs for important health needs. Our products are concentrated in major therapeutic areas: Cardiovascular/Metabolism, Oncology, Neuroscience, Dermatology, Arthritis Bone, Respiritory, Infectious Disease, Transplant, Opthalmics, GI, Urinary.
We have received 15 new pharmaceutical product approvals in the US since 2000, the most of any pharmaceutical company. Our current product portfolio includes more than 45 key marketed products, many of which are leaders in their respective therapeutic areas. The product development pipeline involves nearly 140 projects – including potential new products as well as potential new indications or formulations for existing products – in various stages of clinical development.
Industry experts have ranked Novartis as a leader for having one of the best combinations of organic growth, pipeline opportunities, and low patent-risk exposure among major companies in the pharmaceuticals industry