Assistant General Manager-RA

Navlakha Management Services; Mumbai; Híbrido; INR 4.200.000 - 7.000.000; Jornada completa

Descripción de la vacante

Navlakha Management Services seeks a seasoned regulatory leader to head its Canada regulatory portfolio, based in Mumbai (on-site or hybrid as applicable). The role focuses on Health Canada submissions and lifecycle management for generic and innovator formulations, requiring 10–15 years in Pharma Regulatory Affairs. B.Pharm / M.Pharm / M.Sc.

qualifications are expected. The ideal candidate will drive end-to-end regulatory strategy for ANDS, NDS, and Supplements, coordinate interactions with

Formación

• 10+ years of hands-on experience handling Health Canada submissions and regulatory filings.
• Strong knowledge of the Food and Drugs Act & Regulations, Post-NOC guidelines, and eCTD Module 1 (Canadian DTD).
• Proven track record of independently managing regulatory projects, agency queries, and stakeholder deliverables.
• Based in Mumbai or willing to relocate.

Responsabilidades

• Lead end-to-end regulatory strategy and dossier preparation for ANDS, NDS, and Supplements in eCTD format.
• Manage Health Canada interactions, including responses to Clarifax, NOD, and NON.
• Oversee CMC documentation, Canadian Product Monograph alignments, and bioequivalence study compliance.
• Navigate Post-NOC changes (Level I, II, III) and lifecycle management activities.
• Mentor the regulatory team and partner with cross-functional R&D, ARD, and Manufacturing units.

Conocimientos

Health Canada submissions

Regulatory leadership

Lifecycle management

eCTD expertise

Cross-functional collaboration

Mentoring

Educación

B.Pharm

M.Pharm

M.Sc.

Descripción del empleo

We are looking for a seasoned regulatory leader to head our Canada regulatory portfolio! If you have strong expertise in Health Canada submissions and lifecycle management, wed love to connect with you.

Role Details:

Position: Assistant General Manager (AGM) - Regulatory Affairs

Market Focus: Canada (Health Canada / TPD)

Location: Mumbai (On-site / Hybrid as applicable)

Experience: 10 – 15 years in Pharma Regulatory Affairs (specifically Canadian generic/innovator formulations)

Qualification: B.Pharm / M.Pharm / M.Sc.

Key Responsibilities:

• Lead end-to-end regulatory strategy and dossier preparation for ANDS, NDS, and Supplements in eCTD format.
• Manage high-stakes Health Canada interactions, including responses to Clarifax, NOD (Notice of Deficiency), and NON (Notice of Non-Compliance).
• Oversee CMC documentation, Canadian Product Monograph (PM) alignments, and bioequivalence study compliance.
• Navigate Post-NOC changes (Level I, II, III) and lifecycle management activities.
• Mentor the regulatory team and partner with cross-functional R&D, ARD, and Manufacturing units.

Ideal Candidate Profile:

• 10+ years of hands-on experience handling Health Canada submissions and regulatory filings.
• Deep knowledge of the Food and Drugs Act & Regulations, Post-NOC guidelines, and eCTD Module 1 (Canadian DTD).
• Proven track record of independently managing regulatory projects, agency queries, and stakeholder deliverables.
• Based in Mumbai or willing to relocate.