Regulatory Affairs Specialist

Hoe Pharmaceuticals Sdn. Bhd.Petaling Jaya, Selangor, Malaysia

30+ hari lalu

Penerangan pekerjaan

Senior HR Executive | Payroll Management | Detail-Oriented

Job Description

Plan, prepare and submit product registration application (new, renewal & variation) to competent authorities in Malaysia and other countries where the company is exporting to.
Follow up on registration applications with relevant authorities and business partners.
Gathering, collating and evaluating a wide range of information via references and various media inclusive the internet.
Collecting, coordinate, evaluating and compile data and documents in a variety of format.
Liaising and negotiating with government agencies and business partners.
Keeping abreast of local and international legislation, guidelines and practices.
Providing advice to other departments as appropriate.

Job Requirement

Self‑discipline and sense of duty, strictly adhere to company policies, administrative procedures and code of conduct.

Degree in pharmacy, biomedical sciences, biochemistry, biotechnology or relevant science field.

Good interpersonal and computer skills.

Self‑motivated with strong initiative and able to work independently in a challenging environment.

Able to prioritise and organise workload, adapting to fit the changing needs of the business.

Able to converse in Bahasa Malaysia and English.

Strong team‑working skills and able to communicate clearly and effectively, verbally and in writing.

Experience in product registration / regulatory affairs and knowledge in pharmaceuticals (New Drug Product) would be an advantage.

Seniority level

Executive

Employment type

Full‑time

Job function

Science, Product Management, and Research

Industries

Pharmaceutical Manufacturing

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Regulatory Specialist • Petaling Jaya, Selangor, Malaysia