Drug Regulatory Affairs

2 weeks ago


Noida, India Docthub Health Tech Private Limited Full time

**Description**

Drug Regulatory Affairs - Job description
- Prepare CTD, ACTD Dossiers and file regulatory submissions.
- Perform assessments of new or revised products.
- Manage complaint documentation (including investigation and closure).
- Respond to inquiries from regulatory bodies.
- Should be technically well versed with requirements for medicines with fare knowledge about medicines, food supplement,
- To Coordinate with relevant department for arranging documents.
- To prepare / compile dossier for allocated products / countries.
- To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc.
- To coordinate with courier agency for dispatches of dossier /samples.
- To make timely entries of submissions / dispatches.

Qualifications:
- A bachelor’s degree in B. Pharma.
- Experienced with (2 years to 6 yrs) both can apply.
- Excellent communication skills.
- Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management.

**Category**

Regulatory Affairs / Pharmacovigilance

**Preferred Education**

MPharm, Regulatory Affairs, BPharm (Bachelor Of Pharmacy)

**Key Skills**

Regulatory Knowledge, Documentation Management, Regulatory Strategy, Communication Skills

**Salary**: ₹25,000.00 - ₹50,000.00 per month

**Experience**:

- total work: 1 year (preferred)

Work Location: In person



  • Noida, India Florencia Healthcare Full time

    **JOB DISCRIPTION ( Drug regulatory affairs )** **1. Drug Regulatory Affairs - Job description** Ø Prepare CTD, ACTD Dossiers and file regulatory submissions Ø Perform assessments of new or revised products Ø Manage complaint documentation (including investigation and Ø closure) Ø Respond to inquiries from regulatory bodies Ø Should be...


  • Noida, India Accredited Consultants Pvt. Ltd. Full time

    **Responsibilities**: - Take regular classes as and when assigned by the HOD - Be regular and punctual in taking the classes of theory as well as Hands on training. - Instruct all the students to attend the classes regularly - Conduct regular internal tests for the students - Submit the list of students absent for the internal tests and reported to the...


  • Noida, India Florencia Healthcare Full time

    Regulatory affairs professionals play a critical role in the drug development process, working closely with other stakeholders to ensure that pharmaceutical products meet regulatory requirements at every stage of development. Some of their key responsibilities include ( CTD/ ACTD DOSSIER PREPRATION ( MARKET ASEAN, CIS ROW ) **Regulatory Strategy...


  • Noida, Uttar Pradesh, India Bhargava HR solution Full time

    This is a full-time on-site role as a Junior Regulatory Affairs Executive located in Noida. The Junior Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and managing regulatory affairs. **Qualifications**: Regulatory Documentation, Regulatory Requirements, and...


  • Noida, Uttar Pradesh, India BHARGAVA HR SOLUTION Full time

    **Role Description** This is a full-time on-site role as a Junior Regulatory Affairs Executive located in Noida. The Junior Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and managing regulatory affairs. **Qualifications** - Regulatory Documentation,...


  • Noida, India talent crafters solutions Full time

    Job Title: Head of Compliance and Legal AffairsLocation: NoidaSalary: 40L-60L per annumExperience: 15-15 yearsJob Description:We are seeking a highly skilled and experienced individual to join our team as the Head of Compliance and Legal Affairs . As a key member of our organization, you will be responsible for ensuring compliance with all relevant laws,...


  • Noida, India talent crafters solutions Full time

    Job Title: Head of Compliance and Legal AffairsLocation: NoidaSalary: 40L-60L per annumExperience: 15-15 yearsJob Description:We are seeking a highly skilled and experienced individual to join our team as the Head of Compliance and Legal Affairs . As a key member of our organization, you will be responsible for ensuring compliance with all relevant laws,...

  • Contract Management

    3 weeks ago


    noida, India PW (PhysicsWallah) Full time

    Job Summary: The Contract Management and Corporate Affairs (M&A) Lead is responsible for overseeing the organization's contract management processes, as well as managing corporate affairs related to mergers, acquisitions, and other strategic initiatives. This role involves drafting, reviewing, and negotiating a wide range of commercial contracts and...

  • Contract Management

    3 weeks ago


    Noida, India PW (PhysicsWallah) Full time

    Job Summary:The Contract Management and Corporate Affairs (M&A) Lead is responsible for overseeing the organization's contract management processes, as well as managing corporate affairs related to mergers, acquisitions, and other strategic initiatives. This role involves drafting, reviewing, and negotiating a wide range of commercial contracts and...

  • Contract Management

    3 weeks ago


    Noida, India PW (PhysicsWallah) Full time

    Job Summary: The Contract Management and Corporate Affairs (M&A) Lead is responsible for overseeing the organization's contract management processes, as well as managing corporate affairs related to mergers, acquisitions, and other strategic initiatives. This role involves drafting, reviewing, and negotiating a wide range of commercial contracts and...

  • Contract Management

    3 weeks ago


    Noida, India PW (PhysicsWallah) Full time

    Job Summary:The Contract Management and Corporate Affairs (M&A) Lead is responsible for overseeing the organization's contract management processes, as well as managing corporate affairs related to mergers, acquisitions, and other strategic initiatives. This role involves drafting, reviewing, and negotiating a wide range of commercial contracts and...


  • noida, India Clarivate Full time

    The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. What you will need: ...

  • Team Lead-CSV

    5 days ago


    noida, India YO HR CONSULTANCY Full time

    TeamLeadCSVLocation:NoidaExperience: 1012YearsMustHave:Experiencein CSV (Computer SystemValidation)Understanding of the regulatoryguidelines for IT systems primarily FDA EMA MHRA andPMDAJD:1.Exposure to pharmacovigilance domain and drug safety applicationsArgus or ArisG/J strongpreference2. Overall 10 Years ofexperience3. Experience with electronicQMS/DMS is...

  • Regulatory Affairs

    3 weeks ago


    Noida, India Corpseed ITES Private Limited. Full time

    Hi Jobseekers, We are looking for executive level Experience - 06 months - 3 years - Hands on experience in quality certification (ISI mark) of different products as per BIS norms. - Working experience in documentation required for quality certification. - Hands on experience in quality testing of various products as per their standards. - Working...


  • Noida, India Vitrana Full time

    Must Have : - Strong knowledge of Oracle Argus functionalities and Argus Safety database and model- Good knowledge of PL/SQL and ability to write queries- Knowledge on Argus DB, Schemas, Sessions and troubleshooting experience- Working experience on modules like Argus configuration System and Business, Argus Interchange/ESM and custom E2b profiles-...


  • Greater Noida, India Manpower Group Full time

    Key Responsibilities:Academic Leadership:- Provide visionary leadership in developing and implementing the academic vision and mission of the dental college.- Foster an environment that promotes excellence in teaching, research, and clinical practice.- Oversee curriculum development, ensuring it aligns with accreditation standards and stays current with...

  • Legal Counsel

    1 day ago


    Noida, India GEDU Services Full time

    Legal Counsel- Local India compliances- Cross-border M&As and Due Diligence- Corporate & Commercial transactions- Interjurisdictional legal issues and conflict of laws- Ad hoc inhouse workJob Location – NoidaWorkdays - 5 days (Work from Office)Key ResponsibilitiesLegal Counsel will be part of the Office of General Counsel in London and will be responsible...


  • Noida, India iimjobs Full time

    Compliance and Legal Officer About Roka: Dating and Matchmaking AppRoka is an innovative dating and matchmaking application, focused on connecting individuals and fostering meaningful relationships. Our platform is designed for both iOS and Android, with a strong emphasis on user experience and interface design.Position Summary:- Roka Dating and Matchmaking...


  • Noida, India iimjobs Full time

    Compliance and Legal Officer About Roka: Dating and Matchmaking AppRoka is an innovative dating and matchmaking application, focused on connecting individuals and fostering meaningful relationships. Our platform is designed for both iOS and Android, with a strong emphasis on user experience and interface design.Position Summary:- Roka Dating and Matchmaking...


  • Noida, India Rocsearch Full time

    Compliance and Legal Officer About Roka: Dating and Matchmaking AppRoka is an innovative dating and matchmaking application, focused on connecting individuals and fostering meaningful relationships. Our platform is designed for both iOS and Android, with a strong emphasis on user experience and interface design.Position Summary:- Roka Dating and Matchmaking...