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
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