Associate- Regulatory Affairs- India Market

2 days ago

Gurgaon, Haryana, India DDReg Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

DDReg Pharma

DDReg Pharma

Full Time

Gurgaon

Posted 5 hours 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

Related Blog Post

Job Features

Job Category

Regulatory Affairs

  • Associate- Regulatory Affairs

    1 week ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...

  • Associate- Regulatory Affairs

    1 week ago

    Gurgaon, Haryana, India DDReg Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    DDReg PharmaDDReg PharmaFull TimeGurgaonPosted 14 minutes agoJob Purpose:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier...

  • Assistant Manager- Regulatory affairs

    2 days ago

    Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Regulatory Affairs Associate

    1 week ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    JOB PURPOSE:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support globalregulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...

  • Manager – Regulatory Affairs

    2 days ago

    Gurgaon, Haryana, India Evergreen Renewables Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    OverviewEvergreen Power is a US-based renewable energy company engaged in developing end-to-end infrastructure, construction and financing of wind and hybrid power projects, in India and US. Team capabilities span over 5000 MW of projects commissioned collectively.Evergreen Renewables is currently offering the position of Manager where you will be playing a...

  • Drug Regulatory Affairs Specialist

    1 week ago

    Gurgaon, Haryana, India Sam Global Bio care Pvt. Ltd. Full time ₹ 3,00,000 - ₹ 3,60,000 per year

    Company: Sam Global Biocare Pvt. Ltd.Location: Gurgaon (Gurugram), Sector 67, HaryanaJob Description:Sam Global Biocare Pvt. Ltd. is looking for a skilled Drug Regulatory Affairs Specialist with a strong understanding of international regulatory guidelines. Our focus is on exporting to the Middle East and expanding into African markets, so familiarity...

  • Assistant Manager- Regulatory affairs

    2 days ago

    Gurgaon, Haryana, India myGwork - LGBTQ+ Business Community Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...

  • Head of Regulatory, Quality and Government Affairs South-Asia

    2 days ago

    Gurgaon, Haryana, India Fresenius Medical Care Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Responsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office. Lead negotiations with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals; establish and maintain proactive and professional communication &...

  • Head, Government Affairs

    1 week ago

    Gurgaon, Haryana, India Nothing Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    The Role: The Head of Government Affairs / Relations will be the strategic link between Nothing (including CMF) and India's regulatory and policy ecosystem. As the company scales its India manufacturing base and global ambitions, this role will ensure that our operations and growth plans align with government priorities while actively influencing favorable...

  • R&D SRA Associate Analyst

    6 days ago

    Gurgaon, Haryana, India PepsiCo Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    OverviewR&D Regulatory Affairs Associate Analyst (L6) role provides:Support for PepsiCo concentrate business in India BU markets, to meet demand for compliant business-to-business beverage concentrates enabling innovation and reformulation, leading on critical regulatory compliance programmes meeting fast-paced dynamic regulatory landscape in South Asia...