Job Description – Regulatory Affairs Executive
Position: Regulatory Affairs Executive
Experience: 2–3 Years
Location: Noida Sector 63
Employment Type: Full-Time
Job Summary
We are seeking a detail-oriented and experienced Regulatory Affairs Executive to manage regulatory compliance activities for Medical Devices, Cosmetics, and Drug products. The ideal candidate should have hands-on experience with regulatory documentation, submissions, and the Sugam Portal, along with a strong understanding of CDSCO regulations and compliance requirements.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers and applications.
- Handle product registrations, license applications, and renewals.
- Manage regulatory documentation for Medical Devices, Cosmetics, and Drug products.
- Coordinate with CDSCO and other regulatory authorities regarding approvals and compliance matters.
- Maintain and update regulatory records and documentation.
- Ensure compliance with applicable regulatory requirements and guidelines.
- Monitor regulatory changes and communicate their impact to internal stakeholders.
- Work on the Sugam Portal for submissions, tracking applications, and obtaining approvals.
- Support audits, inspections, and regulatory assessments.
- Liaise with internal teams and clients to ensure timely completion of regulatory activities.
Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related field.
- 2–3 years of relevant experience in Regulatory Affairs.
- Experience in handling Medical Devices, Cosmetics, and Drug regulatory documentation.
- Hands-on experience with the Sugam Portal is mandatory.
- Knowledge of CDSCO regulations and regulatory submission processes.
- Proficiency in MS Office applications.
Skills Required
- Strong documentation and filing skills.
- Excellent communication and interpersonal abilities.
- Good analytical and problem-solving skills.
- Attention to detail and accuracy.
- Ability to manage multiple projects and deadlines.
Preferred Candidate Profile
- Immediate joiners or candidates who can join within 15 days.
- Candidates residing in Noida or Delhi will be preferred.
Interested candidates may share their updated resume at
[email protected] or contact (phone hidden).
Pay: ₹15,000.00 - ₹30,000.00 per month
Perks:
- Cell phone reimbursement
- Paid sick time
- Paid time off
Application Question(s):
- What is your current Location?
- What is your Current Ctc ?
- What is your expected Ctc?
- How much total year of experience you have?
- Do you have exp in medical, cosmetic and Drugs?
Work Location: In person
📌 Regulatory Affairs Executive (Noida)
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