Section Manager - Retail Global Sourcing Regulatory Affairs

Key Responsibility:

• Lead the regulatory affairs team within the designated section, providing guidance, mentorship, and performance management.
• Develop and implement regulatory strategies for product development, approval, and lifecycle management.
• Ensuring that a quality management system is implemented and maintained
• Focusing on the management of authorized activities and the accuracy and quality of record
• Serve as the primary contact for interactions with regulatory agencies, ensuring effective communication and compliance with requests and inquiries.
• Manage regulatory inspections and audits in collaboration with relevant stakeholders.
• Ensuring that suppliers and customers are approved
• Approving any subcontracted activities which may impact on GDP
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
• Stay informed about changes in regulations and guidelines that impact the designated section.

Qualifications:

• Education: Bachelor's degree in Pharmacy, Medical Science or related fields.
• In-depth knowledge of regulatory regulations, standards, guidelines, and submission processes.
• Proven leadership and team management skills, including the ability to guide, mentor, and develop team members.
• Excellent communication and interpersonal skills for interactions with internal teams and regulatory authorities.
• Strong analytical mindset with the ability to assess and communicate regulatory risks.
• Detail-oriented with a strong commitment to maintaining compliance.
• Proficiency in regulatory compliance software and tools.

CP AXTRA | Lotus's

CP AXTRA Public Company Limited.

Nawamin Office: Buengkum, Bangkok 10230, Thailand

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