Drug Regulatory Affairs

3 weeks ago


Delhi Delhi, India Job Provider Baddi Full time

Responsibilities:

- Develop and implement regulatory strategies for drug development, registration, and commercialization in compliance with local and international regulations.
- Coordinate regulatory submissions and responses to regulatory agencies, ensuring accuracy, completeness, and timeliness.
- Maintain up-to-date knowledge of regulatory requirements, guidelines, and trends to inform regulatory strategy and ensure compliance.
- Collaborate with cross-functional teams, including Research and Development, Quality Assurance, Clinical Development, and Manufacturing, to support product development and registration activities.
- Provide regulatory guidance and support to internal stakeholders on matters related to product development, labeling, promotional materials, and post-market activities.
- Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Participate in regulatory agency meetings, inspections, and audits, representing the company's interests and addressing regulatory inquiries.
- Support regulatory compliance activities, including regulatory intelligence, risk assessments, and internal audits.
- Maintain regulatory documentation and databases, ensuring accuracy, completeness, and accessibility.

**Experience**:

- drug regualatory affair: 4 years (required)

Work Location: In person



  • Delhi, Delhi, India Professional Utilities Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...


  • Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time

    Regulatory Affairs Specialist - Legal Metrology and EPR India **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest Legal Metrology and EPR regulations in India. Ensure that all products and processes comply with these regulations. Documentation: Prepare and maintain all necessary documentation required for regulatory submissions,...


  • Delhi, Delhi, India Ample Leap Cognition & Technologies Pvt Ltd Full time

    DESIGNATION/ TITLE Sr. Executive / Assistant Manager - Regulatory Affairs LOCATION NSP, Delhi YEAR OF EXP Minimum 3 yrs QUALIFICATION MSc (Toxicology/Agri/Chem) or similar BUDGET In b/w 8-10Lpa KEY RESPONSIBILITIES ROLES & RESPONSIBILITIES Manage the data gathering and compilation of studies (toxicology, chemical, efficacy) necessary for the...


  • delhi, India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment: ...


  • Delhi, Delhi, India DD NUTRITIONS INDIA Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. Typical duties include: studying scientific and legal documents to check they meet legal requirements Pay: ₹20,000.00 per...


  • Delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Executive / Senior Executive / Assistant Manager Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) WFOResponsibilities:1. Dossier collation and...


  • Delhi, India EasyLegalTax Consultants Private Limited Full time

    About Us: ELT Consultants - Medical Law & Regulatory Consulting & Law Firm, operating its services amongst Hospital, Healthcare, Nutrition & Medical Industry, helps its clients for obtaining licensing, registrations, approvals, NOC’s from the Central and State Regulatory Authorities for the Drugs, Cosmetics, Medical Devices & AYUSH. In addition to that...


  • Delhi, India MED-EL India Privated Ltd Full time

    **Position: Junior Associate - Regulatory Affairs (Medical Devices)** **Location**: **Delhi NCR (Delhi/ Gurgaon)** **Experience: 1-2-year Experience in Medical devices (Fresher with interest in medical devices may also apply)** **Qualifications: B. Pharmacy** **Job Profile**: - Regulatory and Quality Assurance for India Sub-continent to support the...


  • New Delhi, India Vimek Bioconcept Pvt LTd Full time

    Looking for person having experience in European CE Certification - documentation of Medical Device & InVitro Diagnostics. Designation : Regulatory Affairs Executive Dealing with licensioing work with CDSCO, ICMR & other Govt institution Education : DPharma / MPharma / Btech for Pharma regulatory / Medical device Experiance : 2-5 Yrs Job location :...

  • Sr Executive

    3 hours ago


    delhi, India Emami Full time

    Job Objective1. To monitor and involve in vetting claims in Artwork, Advertisements, e-platforms or any other communications directed towards consumers2. Drafting primary responses of legal queries from regulatory bodies3. Liasoning with regulatory bodies for effective solution keeping best-of-interest in mind for organisation4. Vetting & Providing inputs on...


  • New Delhi, India PANAV BIOTECH Full time

    **Informing strategic regulatory controls and providing the worldwide regulatory policy for product development, manufacturing, and registration: It aids the applicant **in advancing a universally accepted product**.** **Development of proper leaflets like a summary of product characteristics, patient information, etc.** **To complete record data of the...


  • Vikaspuri, Delhi, Delhi, India APT Staffing Solution Full time

    Required skill set: #goodcommunicationskills #positiveattitude Experience: Minimum 6 month to 1 Year in DRA /Pharmaceutical Industry Job Location: Vikaspuri-Delhi Salary : Between 25K - 35K In Hand Education: Qualification in Pharmacy is preferable) - Having experience in dossier compilation (CTD ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. -...


  • Naraina, Delhi, Delhi, India TRS Consulting Solution Full time

    Mandate Industry Experience: - Pharma industry like Medical Manufacturing (Tabs/Caps/Inj Manufacturing) etc Job Description & Skill Requirement - Well versed in management of Dossier Preparation (documentation)and quality issued thru various quality management - Exp professional in supplier quality management activities in the medical, pharma industry. -...


  • new delhi, India COLORCON ASIA PRIVATE LIMITED Full time

    Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levelsCoordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officialsCoordinate with Global...


  • Delhi, India MED-EL India Privated Ltd Full time

    **Location**:Delhi NCR (Delhi/ Gurgaon)** **Experience: 1-2-year Experience in Medical devices (Fresher with interest in Medical devices may also apply)** **Qualifications: B. Pharma/ M Pharma only** **Job Profile**: - Regulatory and Quality Assurance for India Sub-continent to support the continuous development, implementation and maintenance of the...


  • New Delhi, India Domnic Lewis International Full time

    We are looking for a Lead Regulatory Affairs who is specialized in Indian market regulatory affairs with good connections in DCGI for a Global Pharmaceutical MNC in Delhi / BangaloreJob Description:We are looking for a Regulatory Affairs Lead to lead regulatory processes for our assigned products, ensuring swift approvals and strict compliance with...


  • Nehru Place, Delhi, Delhi, India MED-EL India Privated Ltd Full time

    **Office Assistant - Regulatory Affairs** An Office Assistant is a professional who oversees clerical tasks, such as sorting and sending mail **Education**: Minimum Graduation in any stream. Excellent communication and interpersonal skills. **Job Profile**: - Good Knowledge of Microsoft Excel and Microsoft office for maintaining import database -...


  • Delhi, India Hansa Medcell Full time

    As a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios.Role: Medical Affairs ManagerExperience: 6 10 YearsLocation: Mumbai (Work from Office)Responsibilities:Handle all Medico Marketing activities & Medical Services, Medical...


  • Kirti Nagar, Delhi, Delhi, India PANAV BIOTECH Full time

    **Informing strategic regulatory controls and providing the worldwide regulatory policy for product development, manufacturing, and registration: It aids the applicant **in advancing a universally accepted product**.** **Development of proper leaflets like a summary of product characteristics, patient information, etc.** **To complete record data of the...


  • Okhla, Delhi, Delhi, India Talisman Hr Solutions Private Limited Full time

    Designation: RA Associate Department: Regulatory Affairs Work location: Delhi Working Days: Mon - Fri Work Timings: 9AM -5 PM **Salary**: Best in industry (On payroll of Talisman HR) Detailed Job description - **RA Associate**: - Preparation and submission of dossiers for product registrations, import licenses and other approvals from regulatory...