Regulatory Affairs Specialist

2 weeks ago


Indiana, Pennsylvania, United States Lupin Full time
Position:
Regulatory Affairs Specialist - EU

Location:
MH, IN

Company:
Lupin

Key Responsibilities:
1. Develop and compile regulatory submissions for European, Australian, New Zealand, and Canadian markets.
2. Address inquiries from regulatory bodies and clients in advanced markets.
3. Collaborate with Research & Development, manufacturing facilities, clinical teams, and relevant business development units.
4. Support the lifecycle management of registered products in these regions by securing necessary variation approvals.
5. Maintain and update departmental databases to ensure accuracy and compliance.
6. Conduct regular reviews of regulatory guidelines and manage electronic submission processes.

Qualifications:
1. A minimum of 1 to 2 years of relevant professional experience in regulatory affairs.

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