Intas Pharmaceuticals is a globally recognized pharmaceutical organization with a robust presence in over 85 countries. As a leading multinational, Intas has achieved remarkable growth, surpassing the $2.5 billion milestone. The company specializes in critical therapeutic areas and is committed to making healthcare affordable through innovative biosimilars and plasma-derived therapeutics. With advanced facilities accredited by top global regulators, Intas is at the forefront of the pharmaceutical industry.
Responsibilities in the Job
The role of a Global Regulatory Affairs professional in the Biologics/Biosimilars division involves:
- Managing regulatory documentation for biosimilars and biologics.
- Preparing and submitting Clinical Trial Applications (CTA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).
- Overseeing lifecycle maintenance of approved products.
- Ensuring compliance with global regulatory requirements.
- Coordinating with cross-functional teams to meet submission deadlines.
- Monitoring updates to global regulatory guidelines and ensuring company practices align with the latest standards.
Qualifications
To excel in this role, candidates must possess:
- An advanced degree in Pharmacy, Life Sciences, or a related field.
- A strong understanding of regulatory requirements across different markets.
- Expertise in regulatory submissions and documentation.
- A thorough knowledge of global regulatory guidelines and processes.
Skills
Key skills required for this position include:
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- Proficiency in regulatory compliance and submissions.
- Excellent analytical and problem-solving abilities.
- Strong attention to detail and organizational skills.
- Effective communication and interpersonal capabilities.
- Ability to work collaboratively with diverse teams.
