Walk-in || Executive/Sr Executive/Asst Manager -Regulatory Affairs

Role & responsibilities

Job Title: Regulatory Affairs Formulation
Designation: Executive / Senior Executive / Assistant Manager
Experience: 2–10 Years
Industry: Pharmaceutical Formulations
Location: Hyderabad
Company: MSN Laboratories

Job Summary

We are looking for experienced Regulatory Affairs professionals with expertise in Formulation Regulatory Affairs to join our team at MSN Laboratories. The role will be responsible for preparation, review, compilation, submission, and maintenance of regulatory dossiers for various global markets.

The ideal candidate should have hands-on experience in CTD/eCTD dossier preparation, regulatory submissions, product registrations, post-approval activities, and coordination with cross-functional teams.

Key Responsibilities

• Prepare, review, and compile regulatory dossiers for pharmaceutical formulations in CTD/eCTD format.
• Handle regulatory submissions for US / EU / Emerging / Regulated markets, depending on business requirements.
• Prepare and review Module 1, Module 2 and relevant sections of Module 3 for formulation products.
• Coordinate with R&D, Analytical, Quality Assurance, Quality Control, Manufacturing, Packaging, Medical Writing and other CFTs for dossier compilation.
• Review technical documents for regulatory compliance and ensure consistency across dossier sections.
• Support preparation and submission of ANDA / MAA / Registration dossiers / variations / amendments / supplements, as applicable to the market.
• Manage post-approval changes, including variations, supplements, renewals, site changes, manufacturing changes, formulation changes and other regulatory lifecycle activities.
• Prepare responses to Regulatory Authority queries/deficiencies in coordination with relevant technical functions.
• Track regulatory submission status, deficiencies, commitments and approvals.
• Ensure submissions are prepared within defined timelines and in accordance with applicable regulatory guidelines.
• Maintain regulatory databases, submission trackers and product registration records.
• Review approved dossiers and regulatory commitments and communicate relevant requirements to internal stakeholders.
• Monitor applicable regulatory guidelines and support implementation of regulatory changes.
• Participate in regulatory strategy discussions for new products and lifecycle management activities.

Desired Technical Skills

• Strong knowledge of CTD/eCTD dossier structure and regulatory submission requirements.
• Good understanding of formulation development and pharmaceutical manufacturing processes.
• Knowledge of ICH guidelines and major global regulatory requirements.
• Experience in preparation/review of regulatory documents for generic formulations.
• Exposure to ANDA/MAA, variations, supplements, amendments and post-approval submissions will be an advantage.
• Good understanding of Module 3 / CMC documentation.
• Ability to review technical documents and identify discrepancies, gaps and regulatory risks.
• Good written and verbal communication skills.
• Strong coordination and project-management skills.

Educational Qualification

• M.Pharm
• Regulatory Affairs / Pharmaceutical Sciences specialization will be an added advantage.

Experience

• 2–5 Years: Executive / Senior Executive – Regulatory Affairs
• 5–8 Years: Senior Executive – Regulatory Affairs
• 8–10 Years: Assistant Manager / equivalent, depending on relevant regulatory experience

Candidates with hands-on experience in Formulation Regulatory Affairs and global dossier submissions are preferred.

Key Competencies

• Regulatory dossier compilation
• CTD/eCTD
• Formulation CMC
• Regulatory submissions
• Post-approval lifecycle management
• Deficiency response
• Cross-functional coordination
• Regulatory compliance
• Documentation and attention to detail
• Time and project management