Sr/Jr Regulatory Affairs- Healthcare/ Pharma- Borivali/ Boisar

3 weeks ago

Borivali, India Pink Sky HR Services Full time

Sr/Jr Regulatory Affairs- Healthcare/ Pharma- Borivali/ Boisar

WFO- 6 days

Key Responsibilities:

  • Prepare, compile, and review dossiers and Drug Master Files (DMFs) for submission to regulatory agencies across developing nations.
  • Analyze and interpret guidelines from WHO, USFDA, EMA, and regional health authorities to ensure documentation meets regulatory standards.
  • Collaborate with cross-functional teams—R&D, manufacturing, quality assurance, and supply chain—to gather required data and documentation.
  • Ensure completeness, accuracy, and compliance of technical documents, including CTD structure.
  • Respond to regulatory queries and provide clarifications or supporting data as needed.
  • Adapt documents to meet region-specific requirements while maintaining confidentiality and data integrity.
  • Track and manage submission timelines and audit readiness.
  • Support inspections and audits by preparing documentation and addressing findings.

Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
  • 3–7 years of experience in pharmaceutical regulatory documentation.
  • Demonstrable experience in preparing dossiers and DMFs for global submissions.
  • Good understanding of ICH guidelines, WHO prequalification, GMP, and local compliance frameworks.
  • Experience working with emerging markets, especially in Africa, Latin America, or Southeast Asia is a plus.
  • Excellent written and verbal communication skills in English.
  • Strong organizational and multitasking abilities.
  • Ability to work independently and coordinate with multiple stakeholders.

Preferred Skills:

  • Familiarity with regulatory submission tools and templates.
  • Knowledge of pharmacovigilance and post-marketing requirements.
  • Exposure to different therapeutic segments such as APIs, formulations, or vaccines.
  • Language skills (Spanish, French, Portuguese) are desirable but not mandatory.

Please share your resume at

Job Type: Full-time

Pay: ₹400, ₹1,000,000.00 per year

Work Location: In person

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