Regulatory Affairs Executive

Role & responsibilities

• Vendor Sourcing & GMP Verification: Research and identify third-party manufacturing facilities in India; verify GMP certifications and collect facility documentation required for regulatory review and audits.

• Regulatory Documentation & Dossier Preparation: Prepare, format, review, and organize technical documents, including Certificates of Analysis (CoAs), product specifications, ingredient lists, manufacturing details, and other records needed for Health Canada submissions and export clearance.

• Manufacturing-Site Visits: Conduct periodic visits to the manufacturing site to collect and verify records, coordinate with relevant teams, follow up on pending documents, and support manufacturing documentation and compliance checks.
• Data Analysis & Data Management: Actively participate in collecting, checking, organizing, analysing, updating, and maintaining product, vendor, manufacturing, and regulatory data in company databases and trackers.
• Cross-Border Coordination: Coordinate with the Indian operations team and Herbayu Wellness Inc. in Canada, sharing requested technical information promptly and supporting regulatory approval processes, including Natural Product Number (NPN) documentation where applicable.

• Export Operations Support: Provide technical product information and documentation required for commercial invoices, packing lists, customs declarations, and other export paperwork.

• SOPs & Process Improvement: Assist in drafting and updating Standard Operating Procedures (SOPs), checklists, trackers, and regulatory databases; use appropriate digital and AI-assisted tools to improve accuracy and efficiency.
• Document Control & Follow-up: Track document versions, identify missing or inconsistent information, follow up with vendors and internal teams, and maintain organized records for review and audit readiness

Preferred candidate profile

• Master of Pharmacy (M.Pharm) preferred; candidates with B.Pharm or a relevant qualification in pharmaceutical sciences, life sciences, or Ayurvedic medicine may also be considered where their experience matches the role.

• 2-3 years of hands-on experience in Regulatory Affairs, Quality Assurance (QA), technical documentation, or export documentation within pharmaceutical, nutraceutical, herbal, or wellness manufacturing.
• Working knowledge of basic Good Manufacturing Practices (GMP) and compliant manufacturing documentation.
• Experience preparing technical dossiers, product specifications, ingredient lists, Certificates of Analysis (CoAs), and controlled documents.
• Familiarity with international export documentation; exposure to Canada/USA regulatory requirements is an advantage.
• Good skills in spreadsheets, document preparation, data handling, and maintaining structured records

Location, Work Arrangement & Working Hours •

Candidates should be based in Pune or be willing to relocate to Pune. • The role offers work-from-home flexibility; however, the employee must attend the Pune office whenever requested by management.

• Periodic visits to the manufacturing site are part of the role. The candidate should be comfortable travelling to the site as required.

• The candidate must be willing to work flexible hours to coordinate with Canada and USA teams, including occasional early-morning or evening calls depending on business needs. Key Competencies

• Strong attention to detail and the ability to manage multiple document checklists and deadlines.

• Analytical approach to data review, validation, organization, and reporting.

• Clear written and verbal communication for cross-functional and international coordination.

• Proactive follow-up skills and the ability to independently obtain missing information from vendors and internal teams.

• Comfort with digital tools, spreadsheets, document systems, and appropriate AI-assisted productivity tools.

• Flexibility, accountability, and willingness to work in a hybrid, coordination-intensive role