Senior Regulatory Executive/Sr. RA Executive

Alvio Pharmaceuticals; Sarkhej; On-site; INR 600,000 - 900,000; Full time

Job summary

Alvio Pharmaceuticals is seeking a Sr. Executive Regulatory Affairs to manage regulatory documentation, dossier compilation, and submissions for products across international markets.

The role involves coordinating with Manufacturing, QA, QC and R&D to ensure timely, compliant submissions and handling queries from regulators. The ideal candidate has 3+ years in regulatory affairs in the pharmaceutical sector, with hands-on ACTD/CTD experience and strong documentation skills.

Qualifications

• Strong knowledge of pharmaceutical regulatory affairs and dossier compilation.
• Hands-on experience with ACTD/CTD and country-specific dossier formats.
• Good understanding of CMC documentation and regulatory requirements.
• Strong document review and analytical skills.
• Ability to independently handle regulatory queries and prepare responses.
• Good coordination and communication skills.
• Strong attention to detail and ability to manage multiple regulatory activities simultaneously.
• Good working knowledge of MS Office, regulatory databases, and document management systems.

Responsibilities

• Compile and review regulatory dossiers in ACTD, CTD, and country-specific formats.
• Prepare, compile, and maintain regulatory documentation as per applicable country-specific requirements.
• Review technical and regulatory documents, including MFR, PVP/PVR, Stability Reports, Process/Product Validation documents, DMF, and other CMC docs.
• Coordinate with Manufacturing, QA, QC, R&D, and other departments/sites to ensure timely, compliant regulatory documents.
• Review documents for accuracy, completeness, consistency and regulatory compliance.
• Handle regulatory queries and deficiency letters independently with internal teams.
• Support preparation and submission of responses to regulatory authorities.
• Maintain regulatory databases, trackers, and document management systems.
• Ensure proper archival and maintenance of regulatory submissions and supporting documents.
• Track submission status, regulatory queries, commitments, and approvals.
• Stay updated on changes in regulatory guidelines and country-specific requirements.
• Support regulatory activities for international markets including Africa, ASEAN, CIS, and LATAM.

Skills

Regulatory affairs

Dossier compilation

ACTD/CTD

CMC docs

Regulatory queries

Coordination

Attention to detail

MS Office

Education

B. Pharm / M. Pharm

Tools

MS Office

Regulatory databases

Document management systems

Job description

Job Description Sr. Executive, Regulatory Affairs

Designation: Sr. Executive Regulatory Affairs
Department: Regulatory Affairs
Qualification: B. Pharm / M. Pharm
Experience: Minimum 3 Years
Industry: Pharmaceutical

Job Summary

We are looking for a detail-oriented and experienced Sr. Executive – Regulatory Affairs to manage regulatory documentation, dossier compilation, and submission activities for pharmaceutical products across international markets.

Key Responsibilities

• Compile and review regulatory dossiers in ACTD, CTD, and country-specific formats.
• Prepare, compile, and maintain regulatory documentation as per applicable country-specific requirements.
• Review technical and regulatory documents, including:
• MFR (Master Formula Record)
• PVP/PVR
• Stability Reports
• Process/Product Validation documents
• DMF (Drug Master File)
• Other CMC and supporting regulatory documents
• Coordinate closely with Manufacturing, Quality Assurance, Quality Control, R&D, and other relevant departments/sites to ensure timely availability and compliance of regulatory documents.
• Review documents for accuracy, completeness, consistency, and compliance with regulatory requirements.
• Handle and respond to regulatory queries and deficiency letters independently, in coordination with relevant internal teams.
• Support preparation and submission of responses to regulatory authorities.
• Maintain and update regulatory databases, trackers, and document management systems.
• Ensure proper archival and maintenance of regulatory submissions and supporting documents.
• Track submission status, regulatory queries, commitments, and approvals.
• Stay updated on changes in regulatory guidelines and country-specific requirements.
• Support regulatory activities for international markets, including Africa, ASEAN, CIS, and LATAM.

Required Skills & Competencies

• Strong knowledge of pharmaceutical regulatory affairs and dossier compilation.
• Hands-on experience with ACTD/CTD and country-specific dossier formats.
• Good understanding of CMC documentation and regulatory requirements.
• Strong document review and analytical skills.
• Ability to independently handle regulatory queries and prepare responses.
• Good coordination and communication skills.
• Strong attention to detail and ability to manage multiple regulatory activities simultaneously.
• Good working knowledge of MS Office, regulatory databases, and document management systems.

Preferred Candidate Profile

• B. Pharm / M. Pharm with minimum 3 years of relevant experience in Regulatory Affairs.
• Candidates with international regulatory exposure will be preferred.
• Experience handling regulatory submissions for Africa, ASEAN, CIS, and/or LATAM markets will be an added advantage.
• Immediate joiners will be preferred.
• Candidates from the pharmaceutical manufacturing/marketing industry with relevant regulatory experience are preferred.