Responsibilities Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines while ensuring good lab and documentation practices. Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development. Perform Formulation optimization with special focus on manufacturability and biopharmaceutical properties of drug products to achieve successful commercial drug product. Carryout & Support Writing and Review of protocols, reports, validation plans and development report to achieve product development in compliance to quality systems. Coordinate with CFT’s and timely escalation to ensure document approvals on time. Support drug product ideation and selection activities with technical due diligence with appropriate development approaches and assessing timelines. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Support in preparing formal correspondence with regulatory agency to get clarity for focused efforts. Support in preparing milestone wise timelines for the allocated programs. Ensure timely execution and delivery of each program milestones and minimize the slippages. Ensure the activities are carried out in compliance with various quality, regulatory and EHS norms. Support and coordinate application of various regulatory licenses required for R&D, clinical, import activities. Ensure timely availability of such licenses. Support in Developing, maintaining, and upgrading lab facility and support facility team to maintain and run lab effectively. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.     Qualification & Experience M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 3 to 7 years in pharmaceutical development and scale-up of products. Preferred area of expertise is Modified Release Oral Dosage forms and/or Immediate Release Oral Suspensions/Solutions. Global Product Development Experience is preferred while the core area should be the US. Experience of developing branded and differentiated products – 505(b)(2) category would be preferred. Experience of working with CROs/CDMOs would be preferred.  

Responsibilities Represent Regulatory Affairs and is responsible for articulating regulatory strategy including regulatory advocacy for development and post approval change activities. Serve as primary interface with FDA and other regulatory agencies. Review all the technical submission documents and provide regulatory feedback to ensure completeness, accuracy, and regulatory compliance. Manage regulatory filings (IND, PIND, Pre-NDA, Pre-ANDA, CGT, PFC, iPSP, Controlled Correspondences, NDA, ANDA, ODD etc.), including authoring scientific briefing book packages, eCTD sections in accordance with regulatory guidelines, applicable federal laws, and statutory requirements. Manage operational aspects of preparing compliant submissions to regulatory agencies. Establish and manage timelines associated with regulatory submissions in alignment with business priorities. Manage and address deficiencies (IR, DRL and CRL) received from FDA within pre-defined timelines, with adequacy and accuracy in consultation with stakeholders. Responsible for managing and tracking regulatory-related changes. Responsible for evaluating post approval change controls as per the regulatory agency guidelines to determine the appropriate reporting category and explicitly defining the necessary conditions and documents needed to implement the change. Manage archival of regulatory submissions, contact reports and correspondence logs. Provide regulatory guidance on requirements for development projects, as required. Keep abreast of current regulations and regulatory guidance, assessing impact to assigned projects and internal processes. Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department. Develop collaborative and respectful relationships with internal and external partners, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.     Qualification & Experience Master of Pharmacy (M. Pharm): Minimum of 12 years of pharmaceutical industry experience; minimum of 8 years of regulatory experience; clinical experience preferred. Excellent organizational, interpersonal, verbal, and?written communication skills, strong grammar, and?proofreading/editing skills, and MS Office skills are required. Track record of successfully working with cross-functional teams, including external partners  

Responsibilities Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Support for updates in system for License withdrawals Operate in line with internal SOPs and policies Adhere to standard turnaround timelines Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values Assist in ensuring internal regulatory processes and procedures are well documented Assist in remediation activities Support the teams in ADHOC activities Shares the learning time to time with the team colleagues   Qualificatio & Experience Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Preferred Year Of Experience - 2 to 4 years of experience Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.  

Responsibilities Carry out case processing activities Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments Review case criteria to determine appropriate workflow for case processing Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately Write and edit case narrative Determine and perform appropriate case follow-up, including generation of follow-up requests Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database Determine reportability of scheduled reports, ensuring adherence to regulatory requirements Consistently apply regulatory requirements and Pfizer policies Participate, as appropriate, in local, internal and external safety activities.     Qualification & Experience Top 10 graduating students of Pharm. D or M. Pharm (Pharmacovigilance/Pharmacology/Pharmacy Practice) or B. Pharm. We prefer students graduating in 2024 over 2023 graduates. But if the graduating students can’t receive their provisional certificates before Jun 2024, we are okay to consider 2023 graduates.  

Responsibilities Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment: Step 1 Assessment for Nitrosamine risk Step 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs). Submission Execution: Author required CTD sections for filing of supplements /variations,ensuring effective data presentation and quality, as per the finalized GRSD supporting GRS CMC. Support the data alignment team related to RPS Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Works under supervision. Performs all assignments using established procedures and general instructions on the process. Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.     Qualification & Experience Bachelors or Master in Science / Pharmacy Preferred Experience Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.  

Responsibilities   Jointly develop the market/local KOL engagement plan with other MSLs, identify and segment KOLs according to their scientific interest and related affiliations and build the KOL network pre- and post-launch. Engage with KOLs using deep scientific expertise and knowledge of AZ's marketed products and compounds in development. Provide support to the Global Medicines Development (GMD) team on clinical site identification and patient recruitment for Phase I, II & III studies. Create opportunities to complement existing flow of clinical data for AZ's products in line with stakeholder needs, i.e., by identifying pre-clinical, clinical and post-marketing study investigators in alignment with the Development Plan, and engaging in discussions on the ISS Programme with potential investigators. Provides support to the internal Global Medicines Development (GMD) team on clinical site identification Engage with the medical / scientific community in a highly credible, balanced/objective way, representing AZ's dedication to and excellence in science Prepare and give relevant high level medical science presentations at congresses, symposia and scientific meetings Provide support for content development, agreeing agendas and delivery of effective clinical presentations e.g., advisory boards Help to develop medical science literature, i.e., write, edit and publish scientific articles and papers   Qualification & Experience MBBS/MD-Pharmacology Sound knowledge of basic research, drug discovery, drug development, clinical environment Experience in pharmaceutical industry, health care or research environment Proven ability to understand, assimilate and communicate scientific information Proven track record to engage and develop lasting relationships with key thought leaders in complex clinical environments  

Responsibilities Independently handle clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied. As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS). Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements. Be a strategic problem solver and demonstrate strategic review capabilities. Proactively collaborative with other functions at the program level. Support the development of Clinical Regulatory Writing Managers. Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.   Qualification & Experience Life Sciences degree in an appropriate field. Significant medical writing experience in the pharmaceutical industry or CRO. Ability to advise and lead communication projects. Understand drug development and communication process from development, launch through life cycle management.  

Responsibilities As a Director, you will provide International CMC RA expertise across the business functions, lead key business improvement initiatives, and provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product. You will also lead knowledge sharing and provide coaching both within CMC RA and wider business functions. Qualification  & Experience Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science. Breadth of knowledge of manufacturing, project, technical and regulatory project management. Strong understanding of regulatory affairs globally Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products  

Responsibilities Do Literature search for a given step(s) / molecule (STN/Sci finder) Organize for relevant patents and papers from literature Develop a most economical / eco-friendly commercially viable technology at bench scale Co-ordinate with Analytical members and prepare reports like safety Upscale developed technology at Kilo Lab/ Pilot /Plant Scale and to take care of up-scaling problems     Qualification & Experience MSc- 3+ Yrs of Exp Phd -1-2 Yrs of Exp  

Responsibilities To ensure that the clinical study is conducted according to the approved protocol and applicable regulatory requirements. To protect rights, safety and welfare of subjects. Management of Investigational Products. To ensure that sufficient number of qualified medical, paramedical, and clerical staff is available to conduct the study. To ensure that all staff assisting in study is adequately trained on the protocol, investigational product and their duties. To be aware of regulatory requirements and acceptable standards for conduct of clinical trial and protection of human subjects. To ensure that the data is complete, accurate, legible and internally consistent and maintain timelines. To take all study related medical decisions. To ensure that adequate medical care is provided to the subject for any adverse event, including clinically significant laboratory values. In case of health related problems, the investigator should inform the subject's primary physician about the subject's participation in the trial, if the subject has a primary physician and if the subject agrees to the primary physician being informed. To Review AE / SAE reporting forms after it is filled by the physician / designee. To Provide timely inputs on the protocol To conduct study in compliance with protocol approved by IEC, sponsor and regulatory agencies whenever applicable. To document and explain any deviation from the approved protocol. To ensure initiation of study and proper conduct of study in compliance with the study protocol and GCP requirements and communicate with IEC about any deviation in the protocol.     Qualification & Experience MBBS OR MD 2 - 4 years of experience into Principal Investigator