Senior Global Program Regulatory Manager

Beschreibung

Overall Descriptions
The Sr GPRM works under limited supervision of the regulatory affairs (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 Sr GPRM may act as the RA program lead on programs of limited complexity.
The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams.
The Sr GPRM may act as subject matter expert and/or assume mentoring role.

Primary Responsibilities
Regulatory Strategy
• Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
• May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity
• Coordinates regulatory readiness with other line functions, Country Organizations & Regions
• Represents RA or leads in regional RA 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 lead 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
• May serve as RA subject matter expert
• May assume mentoring role
Life cycle management
• In LCM, the Sr 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
For LCM Sr GPRM acting as Team Leads: Management of several direct reports, including talent recruitment, performance management and development of associates

KPIs
Effective identification of regulatory opportunities, risks and mitigation strategies for the program(s) in the assigned region(s)
2. Successful implementation of global regulatory strategy leading to timely submissions and approvals
3. Successful HA interactions, and with relevant internal stakeholders, to inform and achieve business objectives
4. Fulfillment of all compliance obligations

Additional Information
Supervision provided: Direct reports: 0 - In certain groups may include 0-10 direct reports
Supervision received: Works under limited supervision
Financial Responsibility: Provides input for estimates of internal FTEs and external costs for assigned program(s) (Budget, Cost, Sales, etc.)

Requirements/Preferences
Education Bachelors degree preferred
(Minimum/desirable)
• Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
• Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
• Awareness of post-marketing/brand optimization strategies and commercial aspects.
• ?4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
• Experience in leading cross-functional teams
• Strong collaboration, communication influencing and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities)
• Compliance and Quality mindset
Languages: Fluency in English both written and spoken is requirement as a business language. Additional language is an asset.
Caandidate must be in the GMT+1 zone.