Required Drug Regulatory Affairs

2 days ago


Vadodara, Gujarat, India Exemed Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Company Name: Exemed Pharmaceuticals

Designation - Drug Regulatory Affairs -Officer/Sr Officer

Location - Vadodara ( Corporate Office)

Market: Domestic

Primary Job Descriptions

  1. Having knowledge of SUGAM portal and CDSCO website
  2. Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.
  3. Application of CT-05 / CT- 04
  4. Application of CT-10 / 12/ 13
  5. Application of import Licenses [CT-16/ Form 12/Form 08]
  6. Knowledge of IPC submissions
  7. Form 29 application
  8. Preparation of presentation for Subject Expert committee (SEC)
  9. Product Lifecycle & Management

Additionally, should be well verse with

  1. Preparation of Module 4 & 5 Nonclinical & Clinical data
  2. Preparation of Pack Insert (PI), Patient information leaflet (PIL) and Summary Product Characteristics (SPC)
  3. Literature Search (Nonclinical, Clinical, Formulation etc.)
  4. Preparation of Product Monograph
  5. Preparation of different types of rationales (for FDC, efficacy, dosing etc.)
  6. Aware of BABE Guidelines/ CT Phase III guidelines & Animal Toxicology


  • Vadodara, Gujarat, India Exemed Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...


  • Vadodara, Gujarat, India Ami Lifesciences Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesResponsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.Review and submission of Response to queries raised on DMF by USFDA, and other agencies.Review and submission of Amendments and revisions of Drug Master Files.Review and ensuring the...


  • Vadodara, Gujarat, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job TitleExecutive – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocationBarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you enter the Sun...


  • Vadodara, Gujarat, India Flax Laboratories Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs. Required Candidate profileCandidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory...


  • Vadodara, Gujarat, India Asoj Soft Caps Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    ResponsibilitiesAs a regulatory affairs officer:ensure that a company's products comply with the regulations of the regions where they want to distribute themkeep up to date with national and international legislation, guidelines and customer practicesrespond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.collect, collate...


  • Vadodara, Gujarat, India Apnar Pharma Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Compilation and submission of eCTD dossier for new product application & post approval submissionQuery response, PAS,CBE and annual report, drug listingReview of artwork and submission of labelling sectionMaintain product life cycle.


  • Vadodara, Gujarat, India SUN PHARMA Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job TitleSenior Executive /Manager 2 – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG11A/G11BLocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own...

  • Executive

    3 weeks ago


    Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

    Position Exe Sr Exe Regulatory Affairs Baroda Grade - G12A G11BEducation - B Pharm M PharmExperience - 4 to 6 yearsLocation - R D - Baroda Review all data and documents related to product registrations for various health authorities Compile registration dossiers for submission to various health authorities like - US-FDA Health Canada Europe ...

  • Executive - Ra

    2 weeks ago


    Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

    Job Title Executive - Regulatory and Business Continuity Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your...


  • Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

    Job Title Executive - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As...