98 Dmf Jobs - Page 2

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory. Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

Design in Clutches & DMF Design & Verification in Pass. car & Commercial vehicle segments Working in design activities of Clutch & DMF P1 & P2 projects and FE Team on the design Working in RFQ’s of DMF & Clutches & checking the design feasibility.

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

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

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

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

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

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

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

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

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

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

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

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

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 intermediates or APIs. 8. Making sure that quality related complaints are investigated and resolved. 9. Making sure that materials are appropriately tested and the results are reported. 10. Ensuring Technology Transfer from Pilot Plant Level to Plant Level implementation. 11. Ensure the preparation of DMF and other related information at all the Units. 12. Ensuring Quality management system is followed at the site. 13. Responsible for all the Internal and External Quality Audit and EHS Aspects. 14. Handling regulatory details under guidance of Director(Works) 15. Approving intermediate and API contract manufacturers. 16. Approving changes that potentially impact intermediate or API quality. 17. Ensuring GMP training is providing to all the employees in the site. 18. Ensuring quality culture in the organization on QMS EMS.

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

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 Perform appropriate duties as assigned by management Maintain a safe and clean work space Follow established safety rules and regulation Preferred candidate profile Experience: 3-15 years Qualification: Diploma/BE in Mechanical Engineering or a related field. Preferred Aerospace experience candidates. Proficiency in operating HMC / VMC / CNC machines. Knowledge of machining processes, tooling, and materials. Ability to read engineering drawings. Attention to detail and problem-solving skills. Familiarity with safety procedures. Perks and benefits Accommodation Provided Provident Fund Yearly Bonus Incentives Food provided Contact: 9384175888 (Janarthanan R - HR)

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

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 ensure timely responses to regulatory deficiencies and customer inquiries. Provide regulatory guidance to product development teams and attend Technology Transfer Meetings to support compliance. Maintain and update regulatory databases, ensuring accuracy and completeness. Review and approve regulatory submissions and related documents prepared by team members for compliance. Manage change controls and other relevant documents, including approving them in the HOD's absence. Respond promptly to technical queries from regulatory bodies and customers. Interested candidates share their CV to dinesh.baratam@msnlabs.com Please mention subject line "API RA Manager/AGM profile"

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 regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals. Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance. Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required. Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities. Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations. Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management. Position : Executive Qualification : M.sc Work Location : MSN R&D Center, Pashamylaram. Department : API Regulatory Affairs Dept - ( API RA ) Experience : 1 to 7 Years Job Location : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com

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 artworks Review of DMF Review of extractable, leachable, elemental impurities and nitrosamine assessment, in-use and stability data. Liaise with external stakeholders Archiving of communications and maintenance of status files and database Requirements: Education: Pharma Graduate OR Post Graduate Experience: 02- 08 years Desirable traits: Ability to manage complex projects and timelines in a matrix team environment. Ability to work independently and as part of a team. Should have hands on experience on MS word, PDF professional, eCTD software for ANDA preparation and submission. Interested candidate can share cv on bdcv@alembic.co.in

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

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

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

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 Role & responsibilities International Product filing Registrations and life-cycle management Expertise in Regulatory Norms for regulated markets / emerging market. dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements. Respond to queries raised by regulatory agencies and/or local partners of the above regions. Review and give regulatory feedback on technical documents like process validation, AMV, Stability and composition, labeling, batch records, specification or test methods, etc. Ensure accuracy and compliance of documentation. Artwork recommendations and approvals as per regulatory provisions. Well-versed in ICH guidelines, maintain awareness of legislation and current developments in regulatory affairs Cross-Functional Team Work Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities Support plant teams in regulatory audits, liaison with domestic & export regulatory authority. Assess and approve change controls and update files accordingly . Interested candidates share their CV to narasimharaju.manthena@msnlabs.com