Trainee Executive Apply locations India time type Full Global Regulatory Affairs (PEH GRA) Job Description (JD) Job Title: Annual Report Strategist (CMC)/ Trainee Executive Organization : PEH GRA Line (if applicable): India Strategy Department/Group (if applicable) : Legacy Brands CMC - NDA Annual Report Region and/or Country (if applicable) : Not Applicable Organizational Relationship(s) including to whom the position reports (JD Job Title): Position reports to Manager, Legacy Brands NDA AR CMC. Position Purpose Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines. Primary Responsibilities Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines. Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL. Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines. Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled Reviews technical/supportive information for submission to support AR changes Manages and reviews stability contributions for accuracy and consistency with commitments Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications. Develops technical justification of change for agency submission as needed Updates impacted dossier components as needed Coordinates M3.2.R Ancillary documents as needed Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership Coordinates internal document review and sign off. Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate. Ensures compliance to Pfizer internal procedures and training SOPs (Power 2 Learn). Technical Skill Requirements Knowledge on Regulatory requirements of post approval changes for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs. Knowledge in retrieving information from company’s and regulatory agency databases. Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry. Qualifications (i.e., preferred education, attributes) Preferred Education: Minimum – Postgraduate in Pharmacy / Science

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Matechno Solutions is aggressively hiring for the job profile of Trainee Executive at Hyderabad in Madhapur locality. Kindly go through the FAQs below to get all answers related to the given job. 1. How much salary can I expect? Ans. You can expect a minimum salary of 23,000 INR and can go up to 25,000 INR. The salary offered will depend on your skills, experience and performance in the interview. 2. What is the eligibility criteria to apply for this job? Ans. The candidate should have completed Graduate degree and people who have 1 to 31 years are eligible to apply for this job. You can apply for more jobs in Hyderabad to get hired quickly. 3. Is there any specific skill required for this job? Ans. The candidate should have Good (Intermediate / Advanced) English skills and sound communication skills for this job. 4. Who can apply for this job? Ans. Only Female candidates can apply for this job. 5. Is it a work from home job? Ans. No, it’s not a work from home job and can’t be done online. You can explore and apply for other work from home jobs in Hyderabad at apna. 6. Are there any charges or deposits required while applying for the role or while joining? Ans. No work-related deposit needs to be made during your employment with the company. 7. How can I apply for this job? Ans. Go to the apna app and apply for this job. Click on the apply button and call HR directly to schedule your interview. 8. What is the last date to apply? Ans. The last date to apply for this job is 25-Mar-2023. For more details, download apna app and find Full Time jobs in Hyderabad. Through apna, you can find jobs in 74 cities across India. Join NOW!