Associate- Regulatory Affairs- India Market

4 days ago

Gurugram Haryana, India DDReg Pharma Full time

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
Proficiency in handling SUGAM Portal
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 mínimal 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

  • Manager – Regulatory Affairs

    4 weeks ago

    Gurugram, India Evergreen Renewables Full time

    Overview Evergreen 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...

  • Regulatory Control Associate

    7 days ago

    Gurugram, Haryana, India NatWest Group Full time

    Regulatory Control & Data Management, Finance Regulatory Control Associate - Gurugram, India- Permanent- Full Time#R-00236116 Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. - This role is based in India and as such all normal working days must...

  • Regulatory Associate

    4 days ago

    Gurugram, Haryana, India DDReg Pharma Full time

    DDReg Pharma DDReg Pharma Full Time Gurgaon Posted 5 hours ago **Job Purpose**: **Key Responsibilities**: **Compliance & Lifecycle Management**: Prepare variation and requalification dossiers. Manage regulatory product maintenance across EU, UK, WHO, and other emerging markets. **eCTD/CTD Sequence Review**: Perform Level-1 review of CTD/eCTD sequences for...

  • Assistant Manager- Regulatory affairs

    4 days ago

    Gurugram, India myGwork - LGBTQ+ Business Community Full time

    Job Description 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 aworld where complex diseases are...

  • Regulatory Control Associate, Avp

    7 days ago

    Gurugram, Haryana, India NatWest Group Full time

    Regulatory Control & Data Management, Finance Regulatory Control Associate, AVP - Gurugram, India- Permanent- Full Time#R-00236117 Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. - This role is based in India and as such all normal working days...

  • ▷ [Only 24h Left] Head Regulatory Affairs (india)

    2 weeks ago

    Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

    Reporting to Sr Vice President - Regulatory Affairs Qualification Master s Degree in Pharmacy PhD in Pharmacology or Pharmaceutics desirable Experience 10 years Location Baroda Mumbai Responsibilities Work with various cross-functional teams within the organization to ensure that availability of a development execution and submission...

  • Head Of Regulatory, Quality And Government Affairs South-asia

    10 hours ago

    Gurgaon, Haryana, India Fresenius Medical Care Full time

    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 relationship...

  • ▷ 3 Days Left! R&D SRA Associate Analyst

    2 weeks ago

    Gurugram, India Pepsico Full time

    Overview R&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...

  • Regulatory Control Associate

    5 days ago

    Gurugram, Haryana, India NatWest Group Full time

    Regulatory Control & Data Management, Finance Regulatory Control Associate (9 Months) - Gurugram, India- Fixed Term Contract- Full Time#R-00243053 Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. - This role is based in India and as such all...

  • Medtronic - Director - Quality Assurance & Regulatory Affairs

    15 hours ago

    Gurugram, India Medtronic (Medtronic)(279) Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life.Role Summary. The QARA Director for India will be responsible for leading a team supporting Quality...