[Hiring] Regulatory Affairs Regional Project Manager @Organon

Role Description

The role is a fixed term contractor for 1-4 years.

• Participate in MSA project workstream.
• Regulatory planning globally and alongside other functions within ORD and OMS (e.g., supply, EtE planning and PSM) including efficiency and optimization/simplification strategies.
• Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches).
• Sets up priorities, organizes, oversees and monitors activities towards division’s and country's objectives achievement in compliance with policies and standards.

Qualifications

• Demonstrate deep understanding of the complexity following a manufacturing site change (from strategy developed till implementation).
• Solution oriented and positive working attitude (get things done mentality).
• Collaborative and team oriented.
• Excellent organizational skills and create a smooth operating model for the source of supply changes.

Requirements

• Lead and coordinates E2E regulatory process for supply chain changes as per guidelines for the APJ (including China) region as well as regulatory requirements from other regions globally.
• Supports timely and compliant submission management from RA perspective as well as cross functionally.
• Support planning and project management including KPIs and risk mitigation.
• For assigned products, changes and tasks, stays updated on relevant regional and local regulations and guidelines and develops and maintains positive relationships with key players in the regulatory environment.
• Designs and implements regulatory ad-hoc local action plans, as necessary.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Leads and supports country regulatory affairs into developing supply chain and business continuity strategy and adheres to the cross-functional transition plan.
• Ensures that all internal stakeholders are well informed and following through on schedule adherence.
• Supports first-time right dossier compilation, validates content and supports country for procurement of documents as necessary.
• Participates in establishing and maintaining relevant Standard Operating Procedures as needed.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
• Coordinates with labeling hub Lead and country RA to ensure high quality and timely development of needed labels/artworks.
• Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner according to relevant Artwork Management procedures in support for change.
• Ensures adequate support to other functions to enable compliance in areas related to dossier submission management.
• Secures timely and adequate information and decision-making including escalation and risk mitigation for delays.
• Takes part in cross-functional team as the ORD responsible to provide RA input and strategy advice.
• Keeps abreast of local and international laws.
• Participates in internal managers' meetings at sub-regional and regional level and global regulatory workgroups on selected issues.
• For new regulations, identifies and tracks changes/trends that might impact Organon business.
• Sets up priorities, organizes, oversees and monitors supply optimization activities towards division's and country's objectives achievement in compliance with policies and standards.
• Maintains a scientific knowledge and expertise.
• Fosters a positive team spirit of the staff.

Benefits

• Remote Work.
• No Travel Required.

Company Description

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

• As an equal opportunity employer, we welcome applications from candidates with a diverse background.
• We are committed to creating an inclusive environment for all our applicants.