Global Program Regulatory Manager Neuroscience 80-100
Global Program Regulatory Manager Neuroscience 80-100
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1 Vacancy
Job Description
Band
Level 4Job Description Summary
As Global Program Regulatory Manager you will work with the support of a RA Program Lead to develop and implement the global regulatory strategy for program(s) through development registration and post approval in the assigned region(s). The Global Program Regulatory Manager is also a member of the Regulatory Affairs sub team and may lead or represent RA in regional or cross functional teams.Job Description
Key Responsibilities:
Regulatory Strategy
- Provide input to global program regulatory strategy including regulatory designations & innovative approaches
- Coordinates regulatory readiness with other line functions Country Organizations & Regions representing Regulatory Affairs (RA) or leads in regional RA or crossfunctional activities providing strategic input into cross functional deliverables
- Contributes to the development and maintenance of key documents determines the requirements and coordinates the activity for Health Authority (HA) interactions
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 registrations and post approval applications and the preparation review and maintenance of local product information as assigned
- Lead regulatory activities during HA reviews responding to questions and HA interactions
Regulatory Excellence & Compliance
- Ensures timely RA input and submission of regulatory compliance and maintenance reports maintaining regulatory information in compliance databases and document management systems
Essential Requirements:
- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD Ph D PharmD) preferred.
- Experience with regulatory submission and approval processes in 1 or more major regions.
- Experience in a global/matrix environment or cross functional teams in the pharmaceutical industry.
- Experience in HA negotiations.
- 24 years involvement in regulatory and drug/biologic development spanning activities in Phases IIV in the following areas:
- Innovation in regulatory strategy
- Understanding of postmarketing/brand optimization strategies and commercial awareness preferred
- Involvement in dossier submissions and approvals HA negotiations Drug regulatory submission and commercialization in region
- Analysis and interpretation efficacy and safety data
- Regulatory operational expertise
- Strong interpersonal communication negotiation and problemsolving skills
- Basic organizational awareness (e.g. interrelationship of departments business priorities).
Location: Basel Hybrid working requirement 3 days / 12 days per month in office.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together to Diversity & Inclusion:
We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
*Restrictions on flexible working arrangements may apply and will be discussed at interview if applicable
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an email to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Clinical Trials DetailOriented Drug Development Lifesciences Negotiation Skills Regulatory ComplianceRequired Experience:
Exec
Employment Type
Full-Time
