Regulatory Manager

2 weeks ago

Mumbai Navi Mumbai Panvel, India Career Path Hr Solutions Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Industry: Pharmaceutical

Location: Chembur East, Mumbai

About the Company:

A reputed pharmaceutical organization with over 75 years of excellence in the healthcare sector. Renowned for pioneering the introduction of life-saving critical care molecules and vaccines in India, the company is committed to innovation and delivering quality healthcare solutions

nationwide.

Working Days & Hours

  • Working Days: Monday to Saturday (2nd & 3rd Saturdays Off)
  • Working Hours: 10:00 AM to 7:00 PM

Job Title: Regulatory Affairs

Location: Chembur East

Industry: Pharmaceutical

Key Responsibilities

  • Regulatory Expertise: Oversee regulatory processes for pharmaceutical finished formulations across CIS, LATAM, and Africa regions.
  • Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy, compliance, and timely submissions.
  • MOH Query Response: Address and resolve Ministry of Health (MOH) queries for submitted dossiers within deadlines.
  • Compliance Oversight: Review product artworks, labels, and samples for adherence to regulatory guidelines.
  • International Coordination: Communicate and coordinate with international agents for dossier submissions, follow-ups, and product registrations.
  • Documentation Management: Maintain thorough records of technical documents, product registrations, and related expenses.
  • Team Management: Lead, mentor, and supervise the Regulatory Affairs team to meet regulatory objectives and submission deadlines.

Requirements

  • Proven expertise in regulatory affairs for pharmaceutical finished formulations in CIS, LATAM, and Africa.
  • Strong experience in compiling and reviewing ACTD and CTD dossiers.
  • Proficiency in addressing MOH queries and ensuring timely resolutions.
  • Exceptional attention to detail for reviewing product artworks and samples.
  • Excellent coordination skills for managing international agent communications and submission processes.
  • Solid organizational abilities for maintaining comprehensive technical documentation and expense records.
  • Leadership experience in managing and developing high-performing regulatory affairs teams.

Preferred Qualifications

  • Bachelors or Masters degree in Pharmacy, Regulatory Affairs, or a related discipline.
  • Minimum 10+ years of relevant experience in regulatory affairs within the pharmaceutical industry.
  • In-depth knowledge of international regulatory frameworks for CIS, LATAM, and Africa markets.
  • Strong communication, interpersonal, and coordination skills, especially with cross-functional teams and global agents.

  • Regulatory Affairs Executive-API Pharma

    2 weeks ago

    Mumbai, Navi Mumbai, Panvel, India SANVIN group Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & responsibilities1.Ensure proper documentation and fulfillment of statutory requirements with regards to variousFDA authorities.Collect information from various departments and prepare DMFs, Dossiers, amendmentsand supplements etcSubmit them to the pertinent regulatory authorities within a specified time frame to getapproval.Respond to queries as they...

  • Regulatory Specialist

    1 week ago

    Navi Mumbai, Maharashtra, India DECCO Postharvest Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    POSITION :Regulatory SpecialistAREA :R&D and InnovationBASED AT :India (Turbhe Office, Navi Mumbai)REPORTING DIRECT :Global Regulatory CoordinatorREPORTING MATRIX :Global Head R&DMISSION OF THE ROLE:The Regulatory and Technical Specialist will be a key driver of Decco's regional regulatory strategy and a critical link to global regulatory projects as well as...

  • Regulatory Consultant

    3 weeks ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Consultant

    3 days ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Consultant

    2 days ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Manager

    7 days ago

    Mumbai, Maharashtra, India Adani Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with all applicable laws and regulations in the construction industryMonitor and evaluate regulatory requirements for construction projects and provide guidance to project teamsCoordinate with internal teams, external consultants, and regulatory authorities to obtain necessary...

  • Regulatory Consultant

    3 weeks ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Consultant

    3 weeks ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory Consultant Company Information We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Consultant

    3 weeks ago

    Navi Mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory Consultant Company Information We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...

  • Regulatory Consultant

    2 days ago

    navi mumbai, India Metina PharmConsulting Pvt. Ltd. Full time

    Position – Regulatory Consultant Company Information We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in...