Global Program Regulatory Manager

Job Purpose :
The GPRM works under the supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy through development, registration and post approval in the assigned region(s).
The GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams.

Major Responsibilities but not limited to:

Regulatory Strategy :

• Provides input to global program regulatory strategy, including regulatory designations & innovative approaches. Coordinates regulatory readiness with other line functions, Country Organizations & Regions. Represents RA or leads regional or cross-functional activities.
• Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc)• Contributes to the development and maintenance of the Core Data Sheet (CDS). Determines requirements and coordinates activities for Health Authority (HA) interactions. May facilitate HAs meetings together with RA program lead. May serve as local HA liaison (e.g., FDA or EMA).

Regulatory Submissions:
• Leads planning, preparation and submission of clinical trials. Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.

Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents.
• Contributes to preparation, review and maintenance of local product information in their assigned region. Leads regulatory activities during HA reviews including response to questions and HA interactions.

Regulatory Excellence and Compliance:

• Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions.
• Maintains regulatory information in compliance databases and document management systems.

Life cycle management:

• In LCM, the GPRM may report to the LCM-(Sr)GPRD, and focus on one of the following subject matter expertise. Maintenance: preparation of selected global regulatory submissions (eg Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio.

Portfolio Transformation: portfolio streamlining activities eg. Pruning and de-registration, divestment/integration, RxGx, portfolio transformation and manufacturing production transfer as applicable.

Business & Operational Excellence: Procurement of key components e.g. registration samples, certificates of pharmaceutical product CPPs, etc. in support to regional regulatory submissions.

Minimum Requirements:

Education: Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred.
• Understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
• ≥2 years involvement in regulatory and pharmaceutical development in 1 or more major regions. Experience in working in cross-functional teams
• Compliance and Quality approach.

Commitment to Diversity & Inclusion: :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.