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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Section Manager - Retail Global Sourcing Regulatory Affairs