Regulatory Manager job opportunity at Sanofi.

Home Jobs In Singapore Tag: Job Regulatory Manager position at Sanofi


DatePosted 20 Days Ago bot
Sanofi Regulatory Manager
Experience: 5-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeMaster's (M.A.)
loacation City of Singapore, Singapore
loacation City of Singap..........Singapore

Job title : Regulatory Manager Hiring Manager: Head of Site Quality Location: Jurong, Singapore   About the Job The Head of Regulatory Site is responsible to assist the Head of Site Quality for ensuring compliance with relevant worldwide Pharmaceutical Regulation & API regulatory filing (e.g. CEP,CMC, Drug Master File (DMF), New Drug Application (NDA), JNDA, NDS & Marketing Authorisation Application (MAA) of the site. Main accountabilities: Defining the potential regulatory impacts of changes made to the site products and services. Acts as the regulatory interface for the site with external and internal partners at the site and within the SANOFI network for evaluating their change requests and maintaining marketing authorizations in all regions of the world Managing the technical writing for the marketing applications of the site products; authoring the variations, the CTD sections impacted by the changes, the renewals of the site products registrations in compliance with all applicable regulations and company processes Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates. Decide and execute the regulatory compliance maintenance program for the site products Providing the regulatory support during site inspections Maintaining a system to ensure regulatory risks are properly identified, tracked, and mitigated Determines priorities and submission strategies with regulatory affairs from central functions and subsidiaries, pharma correspondents, and third parties, and ensures the follow-up of files. Monitoring the regulatory submissions and approvals for the site products Monitoring and anticipating changes in the regulatory environment and determining the impact and implications for the site Developing and implementing regulatory procedures supporting the right operation of the activities Establishing metrics and monitoring data for the regulatory performance to identify trends and issues and to implement action plan Section 2: About the Job Promoting a culture of quality throughout the site organization and ensuring a correct awareness of regulatory processes applicable to the site products Managing the writing of the site master file Additional accountabilities: Decide for which changes a regulatory strategy must be established and provide the information to site operations (D) Decide how to write CTD dossiers and responses to health authority queries (D) Decide and execute the regulatory compliance maintenance program for the site products (D) Review change’s regulatory strategy defined by GRA for the site products and devices (A) Provide the regulatory support during site inspections (A) Inform senior management on the action plan to mitigate regulatory issues (A) Proactively implement remediation action from findings from internal and external audits related to regulatory issues (I) Leads and coordinates the change control committee. Manages topics as SME for change control system. Review and approve documents like Master Manufacturing Batch Records, SOPs, Qualification & Validation Protocols & Reports and any other document relevant to Regulatory Affairs. Monitoring and updating of quality agreements with suppliers and service providers. Leads and coordinates the timely completion of Annual Product Review (if necessary). Review and approve quality events such as deviations, CAPAs to maintain compliance and operational efficiency (if necessary). Other responsibilities that are not included in the above but are related to quality assignments. About You   Education and Experience 5 years of experience in regulatory affairs within the pharmaceutical industry, including preparation and submission of regulatory documents In-depth understanding of regulatory requirements, guidelines, and processes within the pharmaceutical industry Strong project management skills to handle multiple regulatory projects and ensure timely submissions and compliance Excellent analytical skills to interpret regulatory changes, assess their impact, and develop appropriate strategies Effective communication skills to liaise with regulatory agencies, internal teams, and other stakeholders High level of attention to detail to ensure accuracy in regulatory documentation and compliance activities Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Other Ai Matches

Quality Solution Business Expert Applicants are expected to have a solid experience in handling Job related tasks
特药事业部-医学信息沟通代表-潍坊 Applicants are expected to have a solid experience in handling Job related tasks
Area Business Manager - Allergy/ENT - Atlanta N, GA Applicants are expected to have a solid experience in handling GA related tasks
GRA Device Lead (Associate Director) - Digital Health Applicants are expected to have a solid experience in handling Job related tasks
Clean Utilities Technician Applicants are expected to have a solid experience in handling Job related tasks
Closing & Reporting, Budapest Hub, Accountant Applicants are expected to have a solid experience in handling Budapest Hub, Accountant related tasks
糖尿病事业部-医学信息沟通代表-贵阳 Applicants are expected to have a solid experience in handling Job related tasks
Director, Access Strategy - Rezurock Applicants are expected to have a solid experience in handling Access Strategy - Rezurock related tasks
Area Business Manager, Dermatology, Manhattan East, NY Applicants are expected to have a solid experience in handling Dermatology, Manhattan East, NY related tasks
Expert Medical Regulatory Writer Applicants are expected to have a solid experience in handling Job related tasks
Accelerator Digital Product Owner - AI Workflows (Paris) Applicants are expected to have a solid experience in handling Job related tasks
Clinical Trial Coordinator - VIE contract Applicants are expected to have a solid experience in handling Job related tasks
A la recherche d’une alternance dans le domaine de l’HSE ? Contactez-nous ! Applicants are expected to have a solid experience in handling Job related tasks
特药事业部-医学信息沟通代表-洛阳 Applicants are expected to have a solid experience in handling Job related tasks
Associate - Evidence Synthesis Applicants are expected to have a solid experience in handling Job related tasks
Product Line Manager, Digital M&S AI Solutions Applicants are expected to have a solid experience in handling Digital M&S AI Solutions related tasks
糖尿病事业部-医学信息沟通代表-六安 Applicants are expected to have a solid experience in handling Job related tasks
Scientific Sales Executive Applicants are expected to have a solid experience in handling Job related tasks
Controlling Operations CF – Manager Real Estate and Workplace Experience Applicants are expected to have a solid experience in handling Job related tasks
RWE Associate Project Manager Applicants are expected to have a solid experience in handling Job related tasks
Expert Scientific Writer- HEVA Applicants are expected to have a solid experience in handling Job related tasks
Adjoint Encadrement Logistique - CDD Applicants are expected to have a solid experience in handling Job related tasks
Content Editor - Omnichannel Applicants are expected to have a solid experience in handling Job related tasks