354 Dmf Jobs - Page 12

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8.0 - 13.0 years

6 - 9 Lacs

Pune

Work from Office

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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3.0 - 8.0 years

3 - 4 Lacs

Mumbai

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B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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8.0 - 13.0 years

6 - 9 Lacs

Mumbai

Work from Office

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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3.0 - 8.0 years

3 - 4 Lacs

Bengaluru

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B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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8.0 - 13.0 years

6 - 9 Lacs

Bengaluru

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B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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3.0 - 8.0 years

3 - 4 Lacs

Gandhinagar

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B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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8.0 - 13.0 years

6 - 9 Lacs

Gandhinagar

Work from Office

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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3.0 - 8.0 years

3 - 4 Lacs

Jamnagar

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B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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8.0 - 13.0 years

6 - 9 Lacs

Jamnagar

Work from Office

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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3.0 - 8.0 years

3 - 4 Lacs

Ahmedabad

Work from Office

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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8.0 - 13.0 years

6 - 9 Lacs

Ahmedabad

Work from Office

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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10.0 - 15.0 years

9 - 13 Lacs

Hassan

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1. Managing the entire QA and QC activities in the plant. 2. Monitoring, Documentation and implementation of process development. 3. Making sure that there is satiability data to support retest or expiry dates and storage conditions on APIs and /or intermediates where appropriate; and performing product quality reviews. 4. Reviewing completed batch production and laboratory control records of critical process steps before release of the API intermediated for distribution 5. Making sure that critical deviations are investigated and resolved. 6. Approving all specifications and master production instructions, Test methods, Qualifications. 7. Approving all procedures impacting the quality of in...

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6.0 - 11.0 years

5 - 8 Lacs

Vadodara

Work from Office

BSC / MSC Chemistry / Bpharm / Mpharm 6 to 10 Years CTC: 8 LPA Send CV on sdpbharuch@gmail.com with Subject: RA Vadodara Experience in Formulation Pharma Company is Must Free Jobs Share with Your Friends & Colleagues Required Candidate profile Follow: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ

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3.0 - 8.0 years

2 - 5 Lacs

Coimbatore

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Aerospace Engineering: Operator/ Setter/HMC/VMC/VTL/5-Axis/Fanuc/siemens - with Free Food and Accommodation. Role & responsibilities Ability to read and understand Customer drawings & its constituents, Standard Notes, and Standard Operating Procedures Carry out production, inspection, packaging and machine operation duties Set up machinery and ensure all materials are readily available Ability to create and run program to support in the part prove out Ability to maintain and follow all the documents, created to flow the production with no interrupts Capable to work individually at machinery Effectively monitor production equipment Assist the shop technicians and materials clerk as necessary ...

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3.0 - 5.0 years

0 Lacs

Navi Mumbai

Work from Office

1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus

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13.0 - 23.0 years

14 - 24 Lacs

Hyderabad

Work from Office

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensu...

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1.0 - 6.0 years

2 - 7 Lacs

Hyderabad/Secunderabad

Work from Office

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regu...

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2.0 - 7.0 years

4 - 6 Lacs

Vadodara

Work from Office

Alembic Pharma is hiring: The regulatory affairs professional will be responsible for preparation and submission of ANDA, ensuring compliance with current regulatory requirements. Job profile: To execute regulatory plans aligned with business strategy for complex drug products Review of protocols, reports, batch documents, development data received from stakeholders and ensure compliance of documents. To perform gap analysis on regulatory documentation and propose solution and ensure required compliance. Manage documents, prepare and process compilation in eCTD Preparation of ANDA considering US FDA requirements. Preparation of amendments and supplements. Preparation and review of labeling a...

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1.0 - 3.0 years

4 - 6 Lacs

Vadodara

Work from Office

Co-ordination with all departments, collection of documents required for regulatory filing, DMF compilation, API document review for adequacy of regulatory submission, supporting activities for business development

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4.0 - 6.0 years

4 - 6 Lacs

Pune, Mumbai (All Areas)

Work from Office

Must have experience DMF , Master files & Submissions to countries like Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico, Europe ,UK knowledge to submit of INDs, NDAs, and MAAs

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2.0 - 5.0 years

3 - 4 Lacs

Bharuch, Ankleshwar, Vadodara

Work from Office

Technical Documentation Must have documentation experience in COA, MSDS, VQ Filings, APQR, MOA, DMF, Stability data

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2.0 - 7.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 02 to 07 years of experience in FML Regulatory Affairs Job Title: Executive / Senior Executive / Junior Manager Experience: 02 to 07 years in FML RA field Candidates Only. Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Markets : China, Europe, Australia, US, ROW Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills ...

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7.0 - 12.0 years

12 - 14 Lacs

Noida, Kashipur

Work from Office

Ideal candidate will prepare error-free DMF submissions to regulatory authorities. Manage amendments and annual reports, address regulatory queries, ensure compliance in development/validation, assess impurities. Required Candidate profile Please apply only if your qualifications match the requirements.

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2.0 - 5.0 years

3 - 7 Lacs

Noida

Work from Office

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, ...

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1.0 - 3.0 years

2 - 5 Lacs

Ankleshwar

Work from Office

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

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