Regulatory Transversal Projects Executive

1 week ago

Central Singapore Emprego SG Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Permanent**Salary**
- $6,500 - $13,000 Per Month**Date Posted**
- 3 hours agoAdditional Details

**Job ID**
- 94566**Job Views**
- 1Roles & Responsibilities
- Main interface with the Regulatory Affairs team of the distributor between the distributor and the different stakeholders of Sanofi (Regulatory, PV, Medical, different business functions)
- Responsible to interact with the distributor to collect any new regulatory publications, requirements and ensure data base update
- Responsible to monitor with the distributor the timely submission and approval of the dossiers
- Responsible for transversal activities that support Regulatory Zone Organization.
- Responsible to interact with all the appropriate stakeholders to ensure compliance of the products and timely update of the Sanofi data base according to regulatory requirements and Sanofi policies.
- Point of contact for Global Regulatory Affairs (GRA) performance, quality, operations and transversal activities teams to assure countries/MCO are well trained and equipped to perform their activities and deliver commitments to GRA and external stakeholders.

Main Responsibilities:

- Point of contact for internal quality audits and eventual regulatory inspections
- Responsible for quality topics at country level (trainings, local QDs, CAPAs, JD)
- Supports Country/MCO/Zone Head and BU/TA/COE Leads in preparing and reviewing KPI and management reports
- Leads implementation of transversal projects at country level (systems, regulatory policy and intelligence projects, country position paper on regulatory topics, promotional material review, transversal projects)
- Responsible for operational oversight /point of contact to operational teams
- Responsible for administrative activities to support country organization (contracts, budgets, fee payments, e.g.)
- Involvement into cross-functional projects on the local and global level ; may act as PMO in these projects
- Involvement into external activities (local associations, other external platforms)
- Facilitate “one Sanofi” position in front of country HA, aligning priorities between the different GBUs and the regulatory country Zone Head
- Ensure team acts in compliance with companies directives and policies

**Experience**
- 5-years of Regulatory Affairs experience (local, regional or global) within the pharmaceutical industry
- Sound knowledge of the regulatory environment for the countries/ region in scope
- Prior experience working within an international company in project/ program management a plus.

**Education**
- Degree in Pharmacy (preferred) or tertiary education & equivalent.

**Competencies**
- ** Sanofi Leadership Frame:Skills**:Strategic Thinking, Result Orientation, People Leadership, Relationship & Influence
**Behaviours**: Stretch, Take Action, Act of Patients & Customers, Think Sanofi First
- Strong communication skills and proficient in both spoken and written English
- Ability to work in a matrix environment and collaborate across teams
- Continuous improvement mindset and analytical skills

Tags

regulatory

transversal

projects

executive

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