Regulatory Affairs Executive

Herbayu Wellness India; Pune District; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Herbayu Wellness India is seeking a Regulatory Affairs professional to manage GMP verification, export documentation, and cross-border coordination with Canada and the US for Health Canada submissions.

You will prepare technical dossiers, CoAs, product specs, and maintain regulatory databases, while coordinating with vendors and internal teams to ensure audit readiness. Hybrid Pune-based role with site visits as needed.

Qualifications

• 2–3 years in Regulatory Affairs, QA, or export documentation in pharma/nutrition/wellness manufacturing.
• Working knowledge of GMP and compliant manufacturing documentation.
• Experience preparing technical dossiers, CoAs, product specs, and controlled documents.
• Exposure to Canada/USA regulatory requirements is advantageous.

Responsibilities

• Vendor sourcing and GMP verification for third-party facilities in India.
• Prepare and organize regulatory documents for Health Canada submissions and export clearance.
• Conduct site visits to collect/verify records and support compliance checks.
• Collect, check, and maintain regulatory data in company databases and trackers.
• Coordinate cross-border information with India and Canada teams for regulatory approvals.
• Assist in exporting documentation: invoices, packing lists, and declarations.
• Draft/update SOPs, checklists, and regulatory databases; use AI-assisted tools to improve accuracy.
• Track document versions and follow up with vendors and internal teams.

Skills

Attention to detail

Analytical skills

Written and verbal communication

Proactive follow-up

Digital tools

Flexibility

Education

M.Pharm

B.Pharm

Pharmaceutical sciences

Life sciences

Ayurvedic medicine

Tools

Spreadsheets

Document management systems

AI-assisted productivity tools

Job description

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