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Open nowFirst seen 5 days ago

Regulatory Affairs Specialist

Jobskey Consultancy662 open roles

Where
Mumbai, Maharashtra, India
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Your applicationOpen nowRegulatory Affairs SpecialistJobskey Consultancy · Mumbai, Maharashtra, India

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Key Responsibilities:

  • Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.
  • Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.
  • MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories.
  • Compliance: Review product artworks and samples to ensure compliance with regulatory requirements.
  • International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration.
  • Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses.
  • Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.

Requirements:

  • Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets.
  • Experience in compiling and reviewing ACTD and CTD dossiers.
  • Proficiency in handling MOH queries and ensuring timely responses.
  • Strong attention to detail in checking product artwork and samples for regulatory compliance.
  • Ability to effectively coordinate with international agents and manage the dossier submission and registration processes.
  • Solid organizational skills for maintaining technical documentation and tracking expenses.
  • Team management experience, with the ability to lead, mentor, and develop a high-performing team.

Preferred Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or a related field.
  • Minimum 5 years of experience in regulatory affairs in the pharmaceutical industry.
  • Strong understanding of international regulatory requirements for CIS, LATAM, and Africa regions.
  • Excellent communication and coordination skills with cross-functional teams and international agents.

#RegulatoryAffairs #PharmaJobs #Hiring #MumbaiJobs #RegulatoryCompliance #CareerOpportunity #LinkedInJobs #PharmaCareer

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