Ra Manager
1 week ago
Our company is a global animal health company dedicated to supporting customers and their businesses in every better way. They deliver quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and various services.
**Job Descriptions**:
- Ensuring the most timely and optimal approvals of products to market with compliance with government regulations.
- Processing all the registrations.
- Facilitating the approval and maintaining of new and in-line veterinary products in the Philippines and actively assembling, submitting, and managing regulatory submissions to support new product approvals and in-line product maintenance.
- Coordinating and monitoring studies in support of research, marketing/sales, and regulatory objectives (if any). This includes the composition and coordination of regulatory communications including submissions and related activities.
- Ensuring ongoing product availability (permits).
- Identifying portfolio gaps and assisting build recommendations to work closely with VMRD, NPM, or established brand (generic) development strategies.
- Contributing to the development of regulatory strategies for specified projects, as appropriate, including advising and interacting with members of other animal health departments and external bodies.
- Representing the department on global and local project teams, as requested.
- Coordinating and checking product literature translations and artwork preparation in conjunction with the Artwork Coordinator.
- Working closely with a technical colleague on the timely response to pharmacovigilance reports and feedback.
- Meeting the regulatory timelines.
- Providing expert technical knowledge to support the implementation and maximize the success of the overall business strategy.
**Qualifications**:
- Bachelor's degree in Pharmaceutical Science, Pharmacy is required, or M.Sc. is an advantage.
- At least 5 years of experience in regulatory affairs.
- Knowledge of Thailand's animal health market is preferable.
- Ability to solve problems in a concise and logical manner.
- Good interpersonal with negotiation skills, and decision-making.
- Proficiency in English both written and spoken is a must.
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