Regulatory Affairs Specialist - Pharma (10-12 yrs)

Location: Dadar.

Yr of Exp: 10+.

Mandatory: Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this job.

Key Responsibilities:

- Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.

- Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.

- MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories.

- Compliance: Review product artworks and samples to ensure compliance with regulatory requirements.

- International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration.

- Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses.

- Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.

Requirements:

- Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets.

- Experience in compiling and reviewing ACTD and CTD dossiers.

- Proficiency in handling MOH queries and ensuring timely responses.

- Strong attention to detail in checking product artwork and samples for regulatory compliance.

- Ability to effectively coordinate with international agents and manage the dossier submission and registration processes.

- Solid organizational skills for maintaining technical documentation and tracking expenses.

- Team management.