134 Dmf Jobs - Page 6

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or Business / Organization) Regulatory Affairs 4. KEY ACCOUNTABILITIES: ;;;;;;;;;;;;;Accountabilities ;;;;;;;;;;;;;;;;;;;;;;;;;;;Scope of work Regulatory Support Support regulatory due diligence activities pertaining product in-licensing or acquisition (product in clinical development or approved products). Re-evaluate the regulatory strategies following major changes including but not limited formulation, clinical protocol and marketing changes. Participate actively to meetings with regulatory agencies (pre-submission phase, NDA/NDS review phase, post-approval phases) Prepare, review and submit USFDA Investigational New Drug Application (IND) and Health Canada Clinical Trial application (CTA) filings to include but not limited to: new protocols applications, clinical protocol amendments, informed consent forms, clinical summary reports, regulatory correspondences, deviations, safety reports, cost recovery applications, exemptions, CMC amendments. 5. KEY INTERFACES External Interfaces Internal Interfaces Regulatory Agencies Clinical sites, Quality, marketing, clinical, technical services and R and D departments 6. EDUCATION and EXPERIENCE Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this Job.. Education Qualification(Highest ) with Target Institute(s) Bachelor's degree in biology, biochemistry, or other life science Desired Certifications : A minimum of 5 years of related experience. Experience Range : 10 - 12 years No. of years post Highest Qualification : 8 years Desirable experience : 10 to 12 Years of Industrial Experience 7. SKILLS REQUIRED: ;;; Skills Description Proficiency Level (General Awareness; Working Knowledge; Functional Expert, Mastery ) Functional Skills Must be detail-oriented with well-developed organizational and analytical skills Functional Expert Behavioral Skills Must be self-motivated, capable of managing multiple projects in a fast-paced environment. General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

B.Pharm / M.Pharm with 2 to 6 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

Role & responsibilities 1. Preparation of Drug Master File for US, EU and Row countries according to year plan. 2. Preparation and submission of Annual Reports, Amendments and updates to filed DMFs. 3. Preparation and Submission of responses to queries from customer and regulatory authorities. 4. Preparation of Technical information package (TIP) based on customer requirement. 5. Adequacy review of documents required for Drug Master File & TIP preparation like BMR, process validation reports etc. 6. Coordination with R&D, Quality Control and Quality Assurance to collect required documents. 7. Evaluation of impact of changes to the submitted DMF’s. Preferred candidate profile Only API - Industry Experience candidate required.

Role & responsibilities Hiring for the Drug Regulatory Affair: Profile Exposure: US Export Market DMF (Drug Master File) preparation and submission Regulatory Compliance Handling Regulatory Queries Preferred candidate profile : Qualification: B.Pharma / M.Pharma / M.Sc Position: Executive / Senior Executive Experience Required: Minimum 3 years (API domain)

• Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market • Preparation of query response of drug substance for various and less regulated markets and customers. • Preparation of applicant part and closed part for various authorities for different customers. • Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, • Preparation and submission of CEP applications and responses to EDQM via CESP. • Preparation of CEP LOAs & LOA’s and declarations of various customers and authority. • To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers

Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Training (OJT) and take responsibility for multiple tasks as part of multi-skilling efforts. Assist in tracking and reporting key manufacturing performance indicators (KPIs). Apply Lean principles in daily work and actively contribute improvement ideas to relevant stakeholders. Work on machines such as CNC Horizontal Turning Centers, OD Grinding, HMC, and CNC Gear Grinding as assigned / Assembly line to meet the necessary target. Safely handle heavy components using overhead cranes and follow proper placement procedures. Read and understand engineering drawings and apply them in part machining and inspection. Follow 5S, FIFO, Kanban, CIS, and Kaizen practices in day-to-day operations. Your Profile : Diploma / BE.,(from Tier 3 or 4 college) in Mechanical / Automobile/ Manufacturing/ Production/ Metallurgy / Agriculture 0 - 1 Years experience in Production / Assembly as Operator.

Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for Defficiency letter response and timely Respond to defficiency letters 7. To provide Best in class API regulatory support to Customer 8. Knowlege of current regulatory guidelines and ICH guidelines Preferred candidate profile Experience - 05 to 12yrs, Education: M.Sc- Chemistry Preferred only API Pharma industry experience profile. Interested candidate can share their profile on email id amrutar@harmanfinochem.com

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule