59 Dmf Jobs - Page 3

Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and marketing teams to integrate regulatory considerations into the product development and commercialization processes. Regulatory Submissions: Oversee the preparation and submission of all necessary regulatory new dossier filings, and variations, to relevant health authorities in the targeted regions. Market Intelligence: Monitor and analyze evolving regulatory landscapes and market trends to proactively identify opportunities and challenges. Stakeholder Engagement: Build and maintain strong relationships with regulatory agencies, industry associations, and key stakeholders to facilitate smooth regulatory processes. Team Leadership: Lead and mentor a diverse team of regulatory professionals, promoting a culture of excellence, compliance, and continuous improvement. Compliance Oversight: Ensure all regulatory activities adhere to internal policies and external regulations, managing audits and inspections effectively.

collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.

• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements

Job description:- Review of Drug master file (DMF) Evaluation Of analytical Documents - Specifications, method Validations Checking Pharmacopoeial Change with respect to DMF Submissions Familiar with life cycle Management of DMD Changes good command over spoken and written English well Versed with working on computer

Key Responsibilities: Preparation and submission of DMF (Drug Master Files) and other regulatory documents. Handling regulatory queries and compliance with global regulatory agencies. Coordination with R&D, QA, and production teams for regulatory submissions. Maintaining up-to-date knowledge of regulatory guidelines (USFDA, EDQM, TGA, etc.). Ensuring smooth regulatory approvals and post-approval compliance.

Dear Candidates, Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Regulatory Head - API Division" for Shendra, Aurangabad location, who will be responsible for three API units. Role & responsibilities : 1. Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Korea, Brazil and Rest of World. 2. Ensuring timely readiness of dossiers for all submissions. 3. Co-ordination with other departments to resolve the issues and queries related to submitted dossiers. 4. Quality and speedy response to the Regulatory agencies queries and Customer queries. 5. Conduct training on DMF compilation, submission and guidelines to build regulatory team of well-rounded professionals 6. Evaluation of manufacturers of staring material & primary packing material for use in Active Pharmaceuticals Ingredient. 7. Monitoring and communicating new and changing regulations to concern Department. 8. Maintenance of DMF fees and facility fees (self-identification) in accordance to GDUFA Evaluation of change controls and other documents. 9. Maintaining self-identification of our facilities & establishment renewal to US FDA. 10. Review and submission to drug listing (Label) of our API to US-FDA. 11. Maintaining the D&B renewal for our facilities. 12. Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline. Preferred candidate profile : Education : BSc/MSc Experience : 16 to 25yrs of experience in API Pharma Industry into Regulated market Good in Team Management Perks and benefits : As per company standard

2 to 4 years of experience in MS Dynamics AX development. Respond to Dynamics AX support tickets, providing troubleshooting, issue resolution, and ticket closure. Experience in rollouts. (Patch and upgrades from MS). Knowledge and Experience in X++, Forms, Reports, Tables, Classes, Jobs, SSRS, Microsoft Sql server. Knowledge and Experience in Integration using AIF , Custom services, Data entities, DMF. Good communication

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