We are seeking a detail-oriented and analytical Pharmaceutical Products Researcher / Regulatory Affairs professional to join our team in Mumbai this role you will be responsible for conducting research on pharmaceutical products and ensuring compliance with regulatory requirements throughout the drug development and approval process.
- Conduct comprehensive research on pharmaceutical products including literature reviews and data analysis
- Prepare and review regulatory submissions for new drug applications and product registrations
- Interpret and apply pharmaceutical regulations to ensure compliance in product development and manufacturing processes
- Collaborate with cross-functional teams to address regulatory concerns and implement solutions
- Monitor and analyze regulatory trends and updates in the pharmaceutical industry
- Develop and maintain standard operating procedures (SOPs) for regulatory compliance
- Assist in the preparation of technical documents for regulatory filings
- Participate in regulatory agency inspections and audits
- Provide regulatory guidance to internal stakeholders throughout the product lifecycle
- Stay current with evolving regulations and guidelines in the pharmaceutical industry
Qualifications :
- Diploma Pharmacy Pharmaceutical Sciences or a related field
- 3-5 years of experience in pharmaceutical research or regulatory affairs
- Strong knowledge of pharmaceutical regulations and guidelines
- Excellent research skills and ability to analyze complex scientific data
- Proficiency in regulatory submission software and data management tools
- Experience with regulatory submissions and agency interactions
- Strong technical writing skills for preparing regulatory documents
- Understanding of clinical trial processes and Good Manufacturing Practices (GMP)
- Ability to interpret and apply regulatory requirements to product development and manufacturing
- Excellent organizational and time management skills
- Strong attention to detail and analytical thinking
- Effective communication and interpersonal skills for collaborating with cross-functional teams
- Regulatory Affairs Certification (RAC) preferred
- Familiarity with drug development processes and pharmaceutical industry trends
Remote Work :
No
Employment Type :
Full-time
We are seeking a detail-oriented and analytical Pharmaceutical Products Researcher / Regulatory Affairs professional to join our team in Mumbai this role you will be responsible for conducting research on pharmaceutical products and ensuring compliance with regulatory requirements throughout the dr...
We are seeking a detail-oriented and analytical Pharmaceutical Products Researcher / Regulatory Affairs professional to join our team in Mumbai this role you will be responsible for conducting research on pharmaceutical products and ensuring compliance with regulatory requirements throughout the drug development and approval process.
- Conduct comprehensive research on pharmaceutical products including literature reviews and data analysis
- Prepare and review regulatory submissions for new drug applications and product registrations
- Interpret and apply pharmaceutical regulations to ensure compliance in product development and manufacturing processes
- Collaborate with cross-functional teams to address regulatory concerns and implement solutions
- Monitor and analyze regulatory trends and updates in the pharmaceutical industry
- Develop and maintain standard operating procedures (SOPs) for regulatory compliance
- Assist in the preparation of technical documents for regulatory filings
- Participate in regulatory agency inspections and audits
- Provide regulatory guidance to internal stakeholders throughout the product lifecycle
- Stay current with evolving regulations and guidelines in the pharmaceutical industry
Qualifications :
- Diploma Pharmacy Pharmaceutical Sciences or a related field
- 3-5 years of experience in pharmaceutical research or regulatory affairs
- Strong knowledge of pharmaceutical regulations and guidelines
- Excellent research skills and ability to analyze complex scientific data
- Proficiency in regulatory submission software and data management tools
- Experience with regulatory submissions and agency interactions
- Strong technical writing skills for preparing regulatory documents
- Understanding of clinical trial processes and Good Manufacturing Practices (GMP)
- Ability to interpret and apply regulatory requirements to product development and manufacturing
- Excellent organizational and time management skills
- Strong attention to detail and analytical thinking
- Effective communication and interpersonal skills for collaborating with cross-functional teams
- Regulatory Affairs Certification (RAC) preferred
- Familiarity with drug development processes and pharmaceutical industry trends
Remote Work :
No
Employment Type :
Full-time
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