Regulatory Affairs Specialist

Jobskey Search and Selection; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A specialized recruitment firm is seeking a Regulatory Affairs Specialist in Mumbai, India. The role involves managing the regulatory process for pharmaceutical formulations across CIS, LATAM, and Africa. Candidates should have a strong background in regulatory affairs, including dossier management and compliance review. Team management experience and a relevant degree are essential. The position offers an opportunity to work in a dynamic environment with international coordination.

Qualifications

• Proven expertise in the regulatory field of pharmaceutical formulations across various regions.
• Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong attention to detail in assessing product compliance with regulations.

Responsibilities

• Manage regulatory processes for pharmaceutical finished formulations.
• Compile and review ACTD and CTD dossiers for accuracy and compliance.
• Respond to Ministry of Health queries promptly.

Skills

Regulatory Expertise

Dossier Management

MOH Query Handling

Compliance Review

International Coordination

Documentation Maintenance

Team Management

Education

Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or a related field

Job description

About the job Regulatory Affairs Specialist

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 experience, with the ability to lead, mentor, and develop a high-performing team.

Preferred Qualifications:

• Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or a related field.
• Minimum 5 years of experience in regulatory affairs in the pharmaceutical industry.
• Strong understanding of international regulatory requirements for CIS, LATAM, and Africa regions.
• Excellent communication and coordination skills with cross-functional teams and international agents.