Regulatory Manager

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