Regulatory Affairs Regional Project Manager (remote role)

Job Description

The Position

• 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 (eg: 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.

Responsibilities

• Lead and coordinates E2E regulatory process for supply chain changes as per guidelines for the APJ (inc 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 to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.

• Collects relevant public 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 adhere to the cross functional transition plan and provides clear leadership for these.

Supply chain management:

• Planning globally and alongside other functions within ORD and OMS including efficiency and optimization/ simplification strategies

• Leads supply optimization discussions.

Dashboard and analysis:

• Process mapping, KPI and Create dashboard.

• Ensures that all internal stakeholders are well informed and following through on schedule adherence

Compliance:

• Supports first time right dossier compilation, validates content and support country for procurement of documents as necessary.

• Participates in establishing and maintaining of relevant Standard Operating Procedures as needed.

• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labeling and artwork:

• Coordinate 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 and according to relevant Artwork Management procedures in support for change.

• Support supply transition and risk mitigation with different stakeholders

Cross-functional activities:

• 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.

Regulatory environment:

• 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.

Supports region (either APAC/EMEA/Americas) and global Team:

• 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.

Tasks:

• Plan and track on-time initial submissions and RtQs (assumption to have filling plan complete)

• Confirm SKU list including deletions (timing)

• Define the complete package (incl artwork need for submission)

• Continuous period check-in with concerned countries (country connect tracker maintenance)

• Request, chase and track documents (procurement)

• Standardize and harmonize documents (country questionnaire, site declarations etc)

• Track delivery CMC package, ancillary documents, mock-up artwork

• Identify local collisions (global collision in cross functional team)

• Communicate proliferations and master data updates.

• Escalate shifts from the plan and bundling opportunities.

• Identify and escalate any identified risk.

• Communicate or act upon mitigations (eg stock plans, re-distribution)

• Track in Reliant Health Authority (HA) submission and authorizations

Competencies:

• Demonstrate deep understand 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.

Secondary Job Description

Who We Are:

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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: