Sr Executive Regulatory Affairs

Why This Role Matters
This position provides an excellent opportunity for regulatory affairs professionals to expand their career in international pharmaceutical markets. Working at Titan Laboratories Pvt. Ltd., you will gain hands-on experience in global regulatory submissions, compliance standards, and cross-functional collaboration, enhancing your expertise in regulated markets such as EU, UK, Australia, New Zealand, and South Africa.

Job Description
The Sr. Executive – Regulatory Affairs will be responsible for managing and coordinating regulatory documentation and submissions for international markets. The role requires strong knowledge of regulatory requirements, excellent documentation skills, and the ability to work independently while meeting deadlines. The candidate will serve as a key liaison between internal teams, customers, and regulatory authorities.

Key Features of the Role
• Exposure to global regulatory markets including EU, UK, TGA (Australia), New Zealand, and South Africa
• Opportunity to work in a reputed pharmaceutical company with international compliance standards
• Professional growth in regulatory affairs through hands-on experience with regulatory submissions
• Collaboration with cross-functional teams including QA, production, and medical affairs
• Development of analytical and problem-solving skills in regulatory operations

Responsibilities
• Compile and review regulatory dossiers independently for international submissions
• Respond to queries from customers, regulatory authorities, and internal stakeholders
• Coordinate with cross-functional teams for submission preparation and documentation
• Manage end-to-end regulatory submissions for international markets
• Ensure all submissions comply with the relevant regulatory standards and guidelines
• Track submission timelines and maintain documentation records for audit purposes
• Support process improvements and standard operating procedures in regulatory affairs

Required Qualifications
B.Pharm / M.Pharm with a strong understanding of regulatory requirements and documentation processes

Educational Requirements
• Bachelor’s or Master’s degree in Pharmacy
• Solid foundation in pharmaceutical regulations and international submission guidelines

Experience and Skills
• Proven experience handling international regulatory markets
• Expertise in compiling and reviewing regulatory dossiers
• Strong knowledge of global submission processes (EU, UK, TGA, New Zealand, South Africa)
• Excellent communication and coordination skills
• Analytical thinking and problem-solving abilities
• Ability to work independently and manage multiple deadlines

Salary Insights
₹5,00,000 – ₹9,00,000 per annum, depending on experience and skillset

Company Overview
Titan Laboratories Pvt. Ltd. is a reputed pharmaceutical organization committed to quality, compliance, and innovation. The company operates across international markets and provides a professional environment for growth in regulatory affairs and global pharmaceutical operations.

FAQs
• Is international regulatory experience mandatory?
Yes, experience handling EU, UK, TGA, New Zealand, or South Africa submissions is preferred.

• Can this role involve cross-functional coordination?
Yes, the candidate will collaborate with multiple internal teams.

• Is independent work and time management required?
Yes, the role demands working independently and meeting strict submission deadlines.

Application Tips
• Highlight your experience with international regulatory submissions in your CV
• Emphasize documentation expertise and knowledge of regulatory guidelines
• Showcase problem-solving skills and cross-team collaboration experience
• Be prepared to discuss previous experience managing dossiers for global regulatory authorities