Manager - 2

3 weeks ago


Vadodara, India SUN PHARMA Full time

Job Title:

Manager 2

Job Grade:

G11A

Department:

India Regulatory Affairs

Sub-function:

Corporate Relations

Manager’s Job Title:

Senior Manager - 1

Skip Level Manager’s Title:

Senior General Manager

No. of Direct Reports (if any)

Location:

Tandalja-Baroda

Job Summary

Regulatory submissions of drugs and medical devices in India.

Area Of Responsibility

Evaluation of regulatory strategies for products to be registered in India. Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration/import license of drugs and medical devices in India. Evaluation of the documents that need to be submitted with the applications and coordinating with the respective team for finalization. Evaluation and submission of application for getting BE permission for export registration. Evaluation and submission of application for getting permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13. Evaluation and submission of application for getting permission to import drugs for examination, test or analysis in Form-11/Form CT-17. Evaluation and submission of application for getting permission to import drugs in Form 8. Evaluation and submission of applications for getting permission to import medical devices for examination test and analysis in MD-16. Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same. Evaluation and submission of response to the market complaints raised by regulatory authority. Review advertisement of Consumer Healthcare Products and respond to the queries raised by ASCI. Evaluation and submission of application for grant of Registration Certificate to Legal Metrology. Checking of updates on the government regulatory sites.

Work Conditions:

Physical Requirements:

Travel Estimate

Only if required

Education and Job Qualification

M. Pharm

Experience

8- 10 years’ experience required in Regulatory Affairs for India Market.


  • Manager-2

    2 months ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Manager-2**: - Date: Jan 16, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd1. Exposure to routine Microbiology tests with hand on experience 2. Method development, Method Verification and routine analysis in Orals and Non-orals Formulations 3. Area of Experience: - Microbial Enumeration Test - Test for specified...

  • Manager-2

    2 months ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Manager-2**: - Date: Jan 17, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd1. Exposure to routine Microbiology tests with hand on experience 2. Method development, Method Verification and routine analysis in Orals and Non-orals Formulations 3. Area of Experience: - Microbial Enumeration Test - Test for specified...

  • Manager-2

    2 months ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Manager-2**: - Date: Jan 16, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd- Expertise in downstream process development of large molecules recombinant protein and monoclonal antibodies. - Proficient in handling of chromatographic systems. - Should be conversant with interpretation of analytical and process data. -...

  • Manager-2

    1 week ago


    Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    Title:Manager-2**: Date: Jan 16, 2023 Location: Tandalja R&D Company: Sun Pharmaceutical Industries Ltd Expertise in downstream process development of large molecules recombinant protein and monoclonal antibodies. Proficient in handling of chromatographic systems. Should be conversant with interpretation of analytical and process data. Should be proficient...

  • Manager - 2

    2 weeks ago


    Vadodara, India SUN PHARMA Full time

    Job Title:Manager 2Job Grade:G11ADepartment:India Regulatory AffairsSub-function:Corporate RelationsManager’s Job Title:Senior Manager - 1Skip Level Manager’s Title:Senior General ManagerNo. of Direct Reports (if any)Location:Tandalja-BarodaJob SummaryRegulatory submissions of drugs and medical devices in India.Area Of ResponsibilityEvaluation of...

  • Manager - 2

    3 weeks ago


    vadodara, India SUN PHARMA Full time

    Job Title: Manager 2 Job Grade: G11A Department: India Regulatory Affairs Sub-function: Corporate Relations Manager’s Job Title: Senior Manager - 1 Skip Level Manager’s Title: Senior General Manager No. of Direct Reports (if any) Location: Tandalja-Baroda Job Summary ...

  • Manager - 2

    1 week ago


    Vadodara, Gujarat, India SUN PHARMA Full time

    Job Title: Manager 2 Job Grade: G11A Department: India Regulatory Affairs Sub-function: Corporate Relations Manager's Job Title: Senior Manager - 1 Skip Level Manager's Title: Senior General Manager No. of Direct Reports (if any) Location: Tandalja-Baroda Job Summary Regulatory submissions of drugs and medical...

  • Manager - 2

    4 weeks ago


    vadodara, India SUN PHARMA Full time

    Job Title: Manager 2 Job Grade: G11A Department: India Regulatory Affairs Sub-function: Corporate Relations Manager’s Job Title: Senior Manager - 1 Skip Level Manager’s Title: Senior General Manager No. of Direct Reports (if any) Location: Tandalja-Baroda Job Summary ...

  • Manager-2

    2 months ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    1. Exposure to routine Microbiology tests with hand on experience 2. Method development, Method Verification and routine analysis in Orals and Non-orals Formulations 3. Area of Experience: - Microbial Enumeration Test - Test for specified Micro-organisms - Bio-burden Test , - Antimicrobial Effectiveness Test, - Sterility Test , - Bacterial Endotoxin...

  • Manager-2

    3 weeks ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    **Department: F R&D (Non-oral), SPIL, Baroda** **Position: Manager-II (G11)** **Requirements**: - M. Pharm or Ph.D in Pharmaceutics from renounced institute. - Industrial experience from major pharma industries in Non-oral Products: Parenteral product (injection). - Experience in end-to-end parenteral product (injection) product development activities for...

  • Manager-2

    1 week ago


    Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    Department: F R&D (Non-oral), SPIL, BarodaPosition: Manager-II (G11)Requirements: M. Pharm or Ph.D in Pharmaceutics from renounced institute. Industrial experience from major pharma industries in Nonoral Products: Parenteral product (injection). Experience in endtoend parenteral product (injection) product development activities for generic product...

  • manager - 2

    1 week ago


    Vadodara, Gujarat, India SUN PHARMA Full time

    Position: Executive/ Sr. Executive – Regulatory Affairs (API) Location: Baroda Education : M.Sc. (Organic Chemistry/Chemistry/Analytical Chemistry) Job Description: Minimum 5-6 years of experience in regulatory affairs/quality assurance of API Plant or corporate. Good understanding of DMF compilation and lifecycle management...

  • Manager -2

    1 week ago


    Vadodara, Gujarat, India SUN PHARMA Full time

    Position: Sr. Executive/Manager-II – Regulatory Affairs (API) Location: Mumbai Education : M.Sc. (Organic Chemistry) Job Description: Expertise in Control strategy and DMF preparations for US / Europe and other regulated/ emerging markets. Expertise in understanding the deficiencies received and to prepare appropriate response for...

  • Manager -2

    2 weeks ago


    Vadodara, India SUN PHARMA Full time

    Position: Sr. Executive/Manager-II – Regulatory Affairs (API) Location: Mumbai Education : M.Sc. (Organic Chemistry) Job Description: Expertise in Control strategy and DMF preparations for US / Europe and other regulated/ emerging markets. Expertise in understanding the deficiencies received and to prepare appropriate response for...

  • Manager -2

    60 minutes ago


    vadodara, India SUN PHARMA Full time

    Position: Sr. Executive/Manager-II – Regulatory Affairs (API) Location: Mumbai Education : M.Sc. (Organic Chemistry) Job Description: Expertise in Control strategy and DMF preparations for US / Europe and other regulated/ emerging markets. Expertise in understanding the deficiencies received and to prepare appropriate...

  • Manager -2

    4 weeks ago


    Vadodara, India SUN PHARMA Full time

    Key role: Development of multiplex based cytokine release assay and Elispot/ flow cytometry based T cell assays to measure the innate and adaptive Immunogenicity of synthetic peptide products. Job Responsibilities: Responsible for study sample analysis for all pipeline products. Isolation of PBMC from whole blood and maintenance of commercial...

  • Manager -2

    4 weeks ago


    vadodara, India SUN PHARMA Full time

    Key role: Development of multiplex based cytokine release assay and Elispot/ flow cytometry based T cell assays to measure the innate and adaptive Immunogenicity of synthetic peptide products. Job Responsibilities: Responsible for study sample analysis for all pipeline products. Isolation of PBMC from whole blood and maintenance of...

  • Manager-2

    2 months ago


    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Manager-2**: - Date: Jun 28, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd**Job description [Pharmacokinetic Scientist - 5 -7 years]- 1 position** - Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. - Review of BA/BE...

  • Manager - 2

    2 months ago


    vadodara, India SUN PHARMA Full time

    Executive and Sr. Executive Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – China , Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various...

  • Manager-2

    2 months ago


    Vadodara, India Sun Pharmaceutical Industries Ltd Full time

    Expertise in downstream process development of large molecules recombinant protein and monoclonal antibodies. - Proficient in handling of chromatographic systems. - Should be conversant with interpretation of analytical and process data. - Should be proficient in writing document such as BMR, SOPs, Investigational reports etc. - Expertise in downstream...