Senior Executive — Regulatory Affairs (Dossier)

Company Overview

Aravis Pharmaceuticals exports finished dosage form generics from India to markets across Southeast Asia, CIS, and beyond.

Job Summary

The Senior Executive — Regulatory Affairs (Dossier) role focuses on building and maintaining high-quality Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers for submission to national medicines regulatory authorities across ASEAN and other emerging markets. This position is pivotal in ensuring regulatory compliance and expeditious submissions, which directly contribute to the organization's strategic goals.

Responsibilities

• Dossier Preparation & Compilation

  • Prepare new registration and renewal dossier packages in ACTD / CTD format for submissions to ASEAN and other emerging markets.
  • Compile and format all dossier sections: Administrative (Part I), Quality / Chemistry, Manufacturing, and Controls (CMC) (Part II), Non-Clinical (Part III), and Clinical (Part IV).
  • Conduct cross-document audits for consistency prior to submissions, ensuring batch sizes, specifications, assay limits, and testing parameters align across all relevant documentation.
  • Prepare and maintain Product Specifications and Manufacturing Formulae in line with British Pharmacopoeia (BP), United States Pharmacopeia (USP), and/or in-house standards.

• Gap Analysis & Manufacturer Coordination

  • Execute structured gap analyses on dossiers from manufacturing partners against target market requirements.
  • Issue correction requests with distinct severity levels to manufacturers, setting clear remediation deadlines.
  • Review Certificates of Analysis (COA), stability reports, and validation documents for regulatory acceptability.
  • Identify and flag data integrity issues and discrepancies before submission.

• Regulatory Writing & Submissions

  • Draft clear and professional regulatory documents, including cover letters and query responses.
  • Prepare variation dossiers for post-approval changes, including formulation, manufacturing site, and packaging modifications.
  • Oversee the compilation of product labelling and Patient Information Leaflets (PIL), ensuring compliance with market requirements.

• Pipeline & Status Management

  • Maintain an active registration tracker detailing submission statuses, query deadlines, and associated risks.
  • Support Good Manufacturing Practice (GMP) documentation reviews that align with regulatory authority submissions.
  • Maintain transparent communication with the Regulatory Manager regarding dossier statuses and manage escalation of risks that require attention.

Qualifications

• Required

  • Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).
  • 4–7 years of experience in pharmaceutical regulatory affairs, with a minimum of 3 years directly related to dossier compilation or review.
  • Hands-on experience preparing CTD or ACTD format dossiers.
  • Experience with generic drug registration in at least one dosage form category (e.g., tablets, capsules, injectables).
  • Familiarity with International Council for Harmonisation (ICH) guidelines and relevant pharmacopoeias (BP, USP, and others).
  • Proficient in reading and interpreting technical documents and validation reports.

• Preferred

  • Master of Science in Pharmaceutical Sciences or equivalent; additional qualifications in Regulatory Affairs (e.g., RAC, DIA) are advantageous.
  • Experience across multiple dosage forms.
  • Prior experience with regulatory submissions in ASEAN, Middle East, CIS, or other emerging markets.
  • Knowledge of Zone IVb stability requirements and bioequivalence documentation.
  • Understanding of WHO GMP and ASEAN GMP standards.
  • Preference for candidates with 4 years of focused dossier experience over broader, less relevant regulatory exposure.

Experience

• 4–7 years of relevant experience in pharmaceutical regulatory affairs, with a specific emphasis on dossier compilation and review processes.

Environment

• The position is based in India with on-site or hybrid working options available, contributing to a dynamic and fast-paced work environment.

Salary

• Salary details are not specified.

Growth Opportunities

• Opportunities for career advancement within the regulatory affairs department are available based on performance and contributions.

Benefits

• Specific benefits offered are not detailed in the job description.