Regulatory Affairs Spv

PT Darya - Varia Laboratoria Tbk; Daerah Khusus Ibukota Jakarta; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A pharmaceutical manufacturing company in Jakarta is looking for an experienced Regulatory Affairs Spv to manage product registration processes and ensure compliance with regulations. The ideal candidate has at least 2 years of relevant experience, strong communication skills, and is detail-oriented. This is a full-time entry-level position with opportunities for professional growth.

Qualifications

• Minimum 2 years of experience in regulatory affairs for drug product registration.
• Knowledge of local regulatory environment and its impact on strategy.
• Proficiency in written and spoken English.

Responsibilities

• Execute and monitor product registration processes.
• Coordinate with related departments and prepare registration dossiers.
• Ensure compliance with regulations in all regulatory activities.

Skills

Regulatory affairs knowledge

Communication skills

Interpersonal skills

Detail-oriented

Project management skills

Negotiation skills

Teamwork attitude

Quick learner

Job description

Join to apply for the Regulatory Affairs Spv role at PT Darya - Varia Laboratoria Tbk.

Pay Range

This range is provided by PT Darya - Varia Laboratoria Tbk. Your actual pay will depend on your skills and experience. Please discuss with your recruiter to learn more.

Base Pay Range

Responsibilities

• Execute and monitor product registration processes.
• Coordinate with related departments and principals, review documents, and prepare registration dossiers.
• Ensure all regulatory activities (new product, variation, and renewal submissions) comply with regulations and requirements.
• Obtain approvals within committed timelines.
• Consult with managers and department heads on regulatory strategies and approaches.
• Develop good relations with internal and external stakeholders.

Requirements

• Minimum 2 years of experience in regulatory affairs for drug product registration.
• Knowledge of local regulatory environment and its impact on strategy and implementation, especially related to product registration requirements, regulations, and guidelines.
• Strong communication and interpersonal skills.
• Detail-oriented with project management skills from inception to completion.
• Proficiency in written and spoken English.
• Good negotiation skills and teamwork attitude.
• Loyal, responsible, positive attitude, and fast learner.

Additional Details

• Seniority Level: Entry level
• Employment Type: Full-time
• Job Function: Legal
• Industry: Pharmaceutical Manufacturing

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