Corpseed is a prominent player in the compliance and regulatory affairs sector, specializing in various regulatory requirements for medical devices, drugs, and cosmetics. Based in Noida, Uttar Pradesh, Corpseed provides comprehensive services including CDSCO registration, quality certification, and compliance with multiple regulatory standards. The company is dedicated to helping businesses navigate complex regulatory environments and ensuring adherence to industry standards.
Job Role: Drug Regulatory Affairs
As a Drug Regulatory Affairs professional at Corpseed, you will manage and oversee regulatory submissions and compliance for medical devices, drugs, and cosmetics. This role requires a strong understanding of Indian regulatory requirements and the ability to handle technical queries and documentation processes.
Responsibilities:
- Regulatory Submissions: Handle CDSCO registration for medical devices, drugs, and cosmetics, ensuring compliance with relevant rules and standards.
- Documentation Management: Draft, review, and submit regulatory documents and maintain archival records for the Indian market.
- Online Filing: Utilize government websites for application filing and review technical documents before submission on the CDSCO portal.
- Regulatory Compliance: Ensure compliance with Medical Device Rules 2017, ISO standards, BIS registration, ISI/FMCS registration, BEE registration, WPC approval, FDA registration, Legal Metrology registration, Pollution NOC, and waste management compliance.
- Technical Queries: Address and manage technical queries related to CDSCO registration and client needs.
- Quality Certification: Work on documentation for quality certifications and designing testing machines as per Indian standards.
Qualifications:
- Experience: Proven experience in regulatory affairs, particularly with CDSCO and related registrations.
- Knowledge: In-depth knowledge of regulatory frameworks including Medical Device Rules 2017, ISO standards, and various Indian regulatory requirements.
- Skills: Ability to manage documentation, handle technical queries, and ensure compliance with quality certifications.
How to Position Yourself:
To position yourself effectively for this role:
- Highlight Experience: Emphasize your experience with regulatory submissions and compliance, particularly with CDSCO and Indian standards.
- Show Knowledge: Demonstrate your understanding of medical device regulations, quality certifications, and various regulatory processes.
- Detail Skills: Showcase your skills in managing technical queries, documentation, and online application filing.
How to Apply:
Interested candidates should send their resumes to nitisha.kumari@corpseed.com.
