Position Name:
Regulatory Affairs
Organization:
Corpseed
Noida, Uttar Pradesh
Corpseed is a leading consultancy firm in the compliance and regulatory sector, providing end-to-end regulatory solutions. Specializing in medical devices, drugs, and cosmetics, Corpseed ensures adherence to Indian and global regulatory standards.
Qualification:
- B.Pharm, M.Pharm, MSc, BSc, Ph.D
Experience:
- 1 to 2 years in regulatory affairs (especially with CDSCO and Indian regulatory requirements)
Salary:
- Not disclosed (Negotiable based on experience)
Location:
- Noida, Uttar Pradesh
About Corpseed
Corpseed is an expert in managing the regulatory requirements across industries, including medical devices, drugs, and cosmetics. The company offers comprehensive services such as CDSCO registration, quality certification, and ensuring compliance with various Indian regulatory frameworks.
Corpseed operates with a mission to help businesses seamlessly navigate the complex regulatory environments in India, making it an ideal place for professionals looking to gain expertise in regulatory affairs.
Job Role: Drug Regulatory Affairs
As a Drug Regulatory Affairs professional at Corpseed, you will take charge of regulatory submissions, compliance, and documentation related to medical devices, drugs, and cosmetics. This position requires a thorough understanding of the Indian regulatory environment, especially handling technical documentation and responding to queries regarding CDSCO registration.
Key Responsibilities
Regulatory Submissions
- Handling CDSCO registration for medical devices, drugs, and cosmetics
- Ensuring compliance with all relevant Indian standards, such as the Medical Device Rules, 2017.
Documentation Management
- Drafting, reviewing, and submitting regulatory documents.
- Maintaining archival records for the Indian market.
Online Filing
- Filing applications through government websites.
- Reviewing technical documents before submission on the CDSCO portal.
Regulatory Compliance
- Ensuring compliance with various regulatory standards, including:
- Medical Device Rules 2017
- ISO standards
- BIS registration
- ISI/FMCS registration
- BEE registration
- WPC approval
- FDA registration
- Legal Metrology registration
- Pollution NOC
- Waste management compliance
Technical Queries
- Handling technical queries related to CDSCO registration and client-specific needs.
Quality Certification
- Managing documentation for quality certifications.
- Assisting in the design of testing machines as per Indian regulatory standards.
Qualifications Required
Experience
- Proven experience in regulatory affairs, specifically with CDSCO and related submissions.
Knowledge
- In-depth understanding of Medical Device Rules 2017, CDSCO, ISO standards, and other Indian regulatory frameworks.
Skills
- Strong skills in managing regulatory documents and handling complex technical queries.
- Proficiency in using online portals for regulatory submissions.
How to Position Yourself
If you’re applying for this role, here’s how you can stand out:
Highlight Your Experience
- Emphasize your hands-on experience with CDSCO registration and ensuring compliance with Indian regulatory standards.
Showcase Knowledge
- Demonstrate a solid understanding of regulatory processes, including quality certifications and medical device regulations.
Detail Your Skills
- Highlight your ability to manage documentation and technical queries effectively.
How to Apply
Interested candidates should send their resumes to:
Email:
nitisha.kumari@corpseed.com