Full Time
Gurgaon
Posted 2 days ago
Job Purpose:
DDReg is seeking a qualified Regulatory Affairs Specialist to join our team, responsible for ensuring compliance with regulatory requirements for India for a portfolio comprising of New Drugs, Generics, Biologicals, Cosmetics, Medical Devices & Nutraceuticals.
Key Responsibilities:
As a Regulatory Affairs Specialist for India the key responsibilities will include:
- Managing CDSCO regulatory submissions for:
• New Drugs – both Synthetic and Biologicals
• Generics and Biosimilars
• medical devices
• Nutraceuticals
• Cosmetics. - Preparing and reviewing dossiers for registration and import licenses.
- Ensuring compliance with pharmaceutical regulations
- Handling regulatory intelligence and change management processes.
- Managing product lifecycle activities, including amendments and renewals.
- Utilizing the Sugam Portal for regulatory submissions and approvals.
- Obtaining and maintaining various licenses such as CT-06/07/11/13/14/15/ 17/ 19/ 20/ 22/ 23/ 24// 25/ 27; COS-2/4/, MD-15/5/9, Form 41 etc
- Submitting applications for new drug, medical device, and diagnostic kit registrations.
- Liaising with CDSCO/DCGI for application follow-ups and deficiency letter resolutions.
- Proficiency in handling SUGAM Portal
- Submitting applications and obtaining permissions and licenses from FSSAI, Legal Metrology for Nutraceutical products
- Sound understanding of guidelines regarding import of New Drugs, Medical Devices, Diagnostics into India.
- Query replied for the deficiency letters obtained from CDSCO/DCGI.
- Having good track record on obtaining certificates for registration, import license, test license, manufacturing license etc.
Educational Qualifications:
- Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
- Minimum 3+ years of experience in regulatory affairs within the drugs, cosmetics, Nutraceuticals & Medical Devices industry, with a focus on CDSCO regulations and utilizing the Sugam Portal.
- Sound knowledge of CDSCO regulations and guidelines pertaining to Drugs/Cosmetics/Medical Devices especially related to the Sugam Portal.
- Familiarity with the registration process for drugs/ nutraceuticals/ Cosmetics/Medical Devices in India, including dossier preparation and submission requirements via the Sugam Portal.
- Strong understanding of quality management systems and Good Manufacturing Practices (GMP) in the drugs, Cosmetics/Medical Devices industry.
- Excellent attention to detail and ability to interpret complex regulatory information.
- Effective communication and interpersonal skills to collaborate with internal and external stakeholders.
- Proactive problem-solving abilities and ability to work independently with minimal supervision.
- Ability to prioritize tasks, meet deadlines, and adapt to changing regulatory requirements.
Soft Skills:
- Strong communication and interpersonal skills
- Time management and multitasking
- Analytical thinking and collaboration
- Positive, adaptable attitude