
Executive - Regulatory Affairs
19 hours ago
Develop new regulatory policies, processes and SOPs and train key personnel on them
- Provide regulatory input to product lifecycle planning
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Compile, prepare, review and submit regulatory submission to authorities
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
**Job Types**: Full-time, Regular / Permanent
**Salary**: From ₹14,000.00 per month
**Benefits**:
- Health insurance
- Leave encashment
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
**Experience**:
- total work: 3 years (required)
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