Regulatory Affairs Associate III - Mature Product Team
Bangalore, India, 560064
Who we are
The opportunity
Responsible for independently leading, driving and executing all the Regulatory Affairs activities independently for assigned projects, ensuring compliance with global regulatory requirements.
How you’ll spend your day
- Hands-on experience in post-approval change impact assessment (CMC change controls), classification of change category and strategy across various dosage forms and global markets (US, EU, and other worldwide markets), along with other life-cycle management activities.
- Ability to work independently and effectively in a global environment with strong communication skills.
- Solid understanding of ICH and regulatory guidelines for US, EU, APAC, LATAM, and other ROW markets.
- Capacity to integrate both the big picture and detailed analysis.
- Strategic thinking with flexibility to adapt to changes.
- Excellent internal and external communication skills (written and oral) and strong collaboration abilities at local and regional levels.
- Ability to share concepts, ideas, information, and suggestions with management, peers, and other stakeholders.
- Strong risk/benefit analysis skills.
- Proven ability to establish and maintain good working relationships at all levels within the company and with external stakeholders (stakeholder management).
- Effective planning and organizational skills.
- Ability to multi-task, remain detail-oriented, and work under pressure to meet tight deadlines.
Your experience and qualifications
Desired Experience: Minimum 6+ Yrs (for post-graduates)/ 8+ Yrs (for graduates) in core post-approval regulatory activity in US, EU and other international markets for various dosage forms.
Qualification: Graduation/ Post graduation in Science/ Pharma discipline
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