Job Description:
- Responsible for regulatory life cycle maintenance submissions and managing application transitions for products (divested or acquired).
- Lead planning, coordination, and execution of regulatory deliverables.
- Manage submission strategies and procedural/documentation requirements.
- Coordinate cross-functional teams and ensure compliance with health authority regulations.
- Contribute to continuous process improvement and operational activities.
Candidate Profile:
- University Degree or equivalent in Science or related field.
- Minimum 6 years of regulatory experience in biopharmaceuticals.
- Strong project management and leadership skills.
- Excellent communication and cross-cultural collaboration abilities.
- Knowledge of global regulatory frameworks and processes.
Preferred Experience:
- Broad regulatory affairs experience across multiple markets.
- Experience with regulatory project management.
- Familiarity with emerging regulatory and pharmacovigilance trends.
- Proficiency in using Veeva Vault and other regulatory tools.
Skills and Capabilities:
- Proficient in English with cultural awareness.
- Strong scientific and regulatory knowledge.
- Ability to use digital tools for productivity and collaboration.
- Independent problem-solving and continuous improvement mindset.
Additional Information:
- Experience: Minimum 6 years
- Qualification: University Degree or equivalent in Science or related field
- Location: Bangalore, India
- End Date: 30th July 2024