Drug Regulatory Affairs (Domestic Market)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Drug Regulatory Affairs (Domestic Market)
A leading pharmaceutical company in Ludhiana Punjab India is seeking a highly experienced and detail-oriented Drug Regulatory Affairs professional to join our growing team. This full-time position requires a minimum of 5 years and a maximum of 10 years of experience in the Indian domestic market. The ideal candidate will possess a strong understanding of Indian regulatory requirements and a proven track record of success in drug registration and lifecycle management.
Tasks
Manage and oversee all aspects of domestic drug registration including submissions approvals and post-market surveillance.
Develop and implement regulatory strategies for new drug applications and lifecycle management of existing products.
Ensure compliance with all applicable Indian drug regulations and guidelines.
Maintain accurate and up-to-date regulatory records and documentation.
Collaborate with cross-functional teams including research and development manufacturing and marketing to ensure regulatory compliance throughout the product lifecycle.
Provide regulatory expertise and guidance to internal stakeholders.
Stay abreast of changes in Indian drug regulations and guidelines.
Represent the company before regulatory authorities as needed.
Develop and implement regulatory strategies for new drug applications and lifecycle management of existing products.
Ensure compliance with all applicable Indian drug regulations and guidelines.
Maintain accurate and up-to-date regulatory records and documentation.
Collaborate with cross-functional teams including research and development manufacturing and marketing to ensure regulatory compliance throughout the product lifecycle.
Provide regulatory expertise and guidance to internal stakeholders.
Stay abreast of changes in Indian drug regulations and guidelines.
Represent the company before regulatory authorities as needed.
Skills
degree required.
Minimum 5 years maximum 10 years of experience in drug regulatory affairs in the Indian domestic market.
In-depth understanding of Indian drug regulations and guidelines.
Excellent written and verbal communication skills.
Strong organizational and time management skills.
Proficiency in Microsoft Office Suite.
Ability to work independently and as part of a team.
Strong problem-solving and analytical skills.
Minimum 5 years maximum 10 years of experience in drug regulatory affairs in the Indian domestic market.
In-depth understanding of Indian drug regulations and guidelines.
Excellent written and verbal communication skills.
Strong organizational and time management skills.
Proficiency in Microsoft Office Suite.
Ability to work independently and as part of a team.
Strong problem-solving and analytical skills.
We offer you
We offer a competitive salary and benefits package including health insurance paid time off and opportunities for professional development. We are committed to providing a supportive and collaborative work environment where employees can thrive.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
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