- Develop and maintain local PV SOPs/WPs.
- Prepare, review, update, and maintain PV clause in the agreement from PV perspective.
- Manage and/or conduct oversight of RMP-related PV activities including risk minimization measures.
- Maintain current knowledge of all local regulatory PV requirements in the territory, communicate with relevant global/regional PV and ensure compliance with them.
- Product registration and product life cycle management (renewal of license, submission of variations).
- To liaise between manufacturer and Sales & Marketing team regarding label changes.
- To provide regulatory input and assistance in the development and implementation of regulatory strategies.
- Establish local Compliance and Privacy SOPs based on Company Group Global Policies and guidelines, applicable laws and regulations (including the industry code).
- Revise local Compliance and Privacy policies and SOPs on a timely basis.
- Provide regular trainings to relevant functions on Company Group Global Policies and local SOPs, and ensure completion of group Compliance and Privacy training program.
- Perform Compliance risk-assessment, develop and implement a Compliance and Privacy monitoring plan.
- Degree in Pharmacy/Pharmacology.
- Minimum 1 year experience in pharmaceutical industry, particularly in the field of PV and/or RA.
- Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
- Ability to maintain confidentiality of sensitive areas.
- Excellent verbal and written communication skills in English.