Regulatory Affairs Manager

4 days ago


Jakarta, Jakarta, Indonesia Wellesta Full time

Direct message the job poster from Wellesta

HR Generalist | Recruitment | HRBP | We are Hiring

Responsibilities:

  1. Develop and implement regulatory strategies for drug approvals and lifecycle management.
  2. Prepare and submit regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.).
  3. Strong understanding of BPOM regulations and system implementation.
  4. Ensure compliance with FDA, EMA, MHRA, and other regulatory guidelines.
  5. Monitor regulatory changes and provide internal training on compliance updates.
  6. Manage communications with health authorities and respond to regulatory queries.
  7. Proactive to come up with solutions and issue management.

Requirements:

  1. Min. Bachelor Degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  2. Experience: 5+ years in pharmaceutical regulatory affairs.
  3. Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.).
  4. Expertise in preparing regulatory submissions and handling product approvals.
  5. Excellent communication and leadership skills.
  6. Detail-oriented with strong analytical and problem-solving abilities.

Wellesta CPI is the Indonesian subsidiary of Wellesta Holdings Pte Ltd, Singapore; set up to support companies in the Healthcare sector to provide marketing and commercial support for companies that are already operating in Indonesia, as well as multinational corporations that are convinced to enter the Indonesian market.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Pharmaceutical Manufacturing

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