308 Ich Jobs - Page 12

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned with study protocols May Translate requirements into comprehensive reporting development specifications, in collaboration with Report end users Support for utilizing existing standard reports whenever possible and to suggest solutions as needed for any new additional requirements Develop reports and analytics visualizations according to specified requirements, ensuring a "first time right" approach Test developed reports, document results, and provide peer review support as needed Adhere to documentation and process compliance, notifying management of any noncompliance Knowledge of regulatory requirements such as ICH, FDA 21 CFR part 11 and GxP Work cohesively with team members, embracing feedback and suggestions Keeping up to date with new reporting tools, techniques, and industry trends to enhance skills and knowledge Plan for your day, make a to-do list and prioritize your tasks based on clinical study needs and consult Line managers for support Embrace feedback and suggestions, continuously working to enhance knowledge and professionalism in the work environment Participate in departmental/organizational activities/initiatives at the site level to build contacts across the organization, fostering collaboration for the benefit of patients Flexible to work with global stakeholders across different time zones while ensuring business continuity as needed If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Key Responsibilities Work with In-Country teams / Compliance / Tech and passing on key messages to team Drive improvement in processes and services based on gained knowledge Migrate and run BAU for In-Country Reporting function All aspects of tasks related to prevention, detection, assurance and oversight of Regulatory reporting function Timely responses to external and internal queries Build tactical and strategic processes and collaborate with Technology and Change teams to deliver them Ensure adherence to Process Documents including regular up-dation and execution of the same Ensure robust control framework is enriched and followed by Regops team Manage team work allocations and quality delivery Actively participate in group Projects / changes People and Talent Ensure the Regulatory Operations team is appropriately skilled, motivated and enabled to deliver and maintain a high-quality control environment across reporting function Adopt and promote a culture of risk awareness and accountability for controls and processes People need to be team players with the ability to collaborate across global Regulatory Operations team Risk Management Create a control framework that effectively executes prevention, detection, Assurance and oversight processes for In-Country Regulatory Reporting functions Understand the system architecture limitations and remediation plans to ensure impact on day to day reporting can be mitigated Evolve, improve and question processes to ensure the team are working in an environment of continual change while having certainty around how current DOI processes should be completed Ensure timely escalation of errors, omissions and technical issues impacting the performance of the reporting function Provide a daily dashboard of performance to provide visibility of the performance of the reporting function Display exemplary conduct and live by the Groups Values and Code of Conduct Take personal responsibility for embedding the highest standards of ethics, including regulatory and business conduct, across Standard Chartered Bank This includes understanding and ensuring compliance with, in letter and spirit, all applicable laws, regulations, guidelines and the Group Code of Conduct Achieve the outcomes set out in the Banks Conduct Principles Effectively and collaboratively identify, escalate, mitigate and resolve risk, conduct and compliance matters Our Ideal Candidate Experience in handling reconciliation breaks and remediating the same in collaboration with various stakeholders Some experience of regulatory reporting e g MIFID, EMIR, Dodd-Frank reporting and the systems used by banks to report trades Strong understanding of the regulatory landscape including APAC, MIFID, SFTR EMIR, DF,STAYS, BOE etc Excellent communication skills, both externally with the FM clients and internally with stakeholders Previous experience of banking reporting systems, remediation and the messaging between systems An understanding of the key FM / FMO functions in the bank Flexible to change and ?Agileways of working Experience working in a control focused environment Ability to work as part of a global team to meet goals Previous experience of managing a team Knowledge of FM products About Standard Chartered We're an international bank, nimble enough to act, big enough for impact For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours When you work with us, you'll see how we value difference and advocate inclusion Together We Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term What We Offer In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum Flexible working options based around home and office locations, with flexible working patterns Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies everyone feels respected and can realise their full potential

ROLE SUMMARY A productive, hand on programmer who applies technical knowledge of CDISC and practical experience to deliver statistical programming deliverables leveraging CDISC constructs: SDTM, ADaM, and Control Terminology Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible Ensures adherence to high quality programming standards in their daily work ROLE RESPONSIBILTIES Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC , ADaM, and TLF generation. Demonstrate experience working as part of a software development team and fundamental SDLC processes. Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible. Ensures adherence to Pinnacle 21 CDISC validation checks and high-quality programming standards in their daily work. Exhibits routine and occasionally complex problem-solving skills, seeking direction when appropriate. Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place. Will be knowledgeable of software development practices as defined within Pfizer s CDISC development framework. May contribute to department level initiatives. QUALIFICATIONS Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field At least 5 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency Statistical Programming and SAS hand-on experience Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data. Good understanding of ICH and regulatory guidelines Working knowledge of clinical data and relevant data standards Strong written and oral communication skills, and project management skills Proven ability to operate with limited oversight. Knowledge of at least 1 Therapeutic Area Proven ability to manage delivery under tight timelines. CDISC experience require. Pfizer CDARS experience desirable. Work Location Assignment: Flexible Work Location Assignment: Flexible Work Location Assignment: Hybrid Medical #LI-PFE

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy

Execution of the Batch production as per BMRs. Plan the Batch movement as per schedule and maintain the records as per SOPs. Verify the input quantity of raw material, in-process material and intermediates. Allot the manpower as required. Required Candidate profile Previous relevant experience in mid to large scale organization manufacturing: Pharmaceutical Intermediate. Synthetic Aromatics. Organic Specialty Chemicals.

Assist with regulatory compliance tasks for the firm. Research and stay updated on relevant financial regulations. Review client documentation and ensure adherence to KYC/AML procedures. Prepare reports and presentations on compliance topics. Maintain accurate records of compliance activities. Skills Strong attention to detail and accuracy. Ability to understand and interpret complex regulations. Excellent research and problem-solving skills. Strong work ethic and commitment to ethical practices.

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.

Candidate job profile Qualification degree B. Pharm or M. Pharmacy and minimum 3 years experience in dossier preparation (Cis & Latam Market). Job Description Dossier Preparation & Compilation

Job Title: Regulatory Publishing Specialist SUMMARY Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). JOB RESPONSIBILITIES: • Electronically format and publish submission components in line with regional specifications. • Compile and validate electronic submissions in publishing software (Lorenz Docubridge) • Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. • Responsible for overseeing routine submissions, including the creation of submissions in Veeva. • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing standards and procedures. • Identifies and communicates regulatory system enhancement needs or technical issues. • Assists with regulatory inspection activities. • Collaborates with vendors who support Regulatory submission document related tasks. • Provides support and backup to management as needed. JOB REQUIREMENTS: Education • Bachelors Degree Experience • Minimum of 2 years experience with Regulatory Operations • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. • Familiarity with Veeva Vault & Lorenz Docubridge would be advantageous. Requirements • Full-time, office-based position (5 days per week) • Working standard regional hours

Education Masters in Chemistry or Analytical Chemistry Post Graduation in Applied Chemistry Long Description Exposure of analytical method validations of drug substances and drug products for different analytical techniques. Exposure of analytical method validations of drug intermediates. Exposure of Cleaning validations. Experience of handling Chromatography Network systems (Chromeleon) Should be able to perform calibration of different analytical instruments. Exposure of handling of different analytical instruments like HPLC, GC, Dissolution apparatus, UV, IR etc. Exposure of chemical analysis. Exposure of routine analysis and regulatory requirements. Awareness of ALCOA + / FDA and ICH guidelines. Awareness of Good Documentation Practices in the Laboratory. Exposure of failure investigations. (Optional) Work Experience Preferably Between 2-4 years Competencies

Description As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose The Principal Biostatistician will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above. Expertise: Familiarity with statistical principles, CDISC data, and standards. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

In this role, you will: Conduct thorough sanctions screening analysis, including review of transactions and clients against sanctions watchlists Perform alert review to detect sanctions concerns and document decision rationale Review transactions escalated by lines of business and operations to detect sanctions exposure Ensure compliance with OFAC regulations, US sanctions and regional global sanctions programs, as applicable Participate in complex initiatives and identify opportunity for process improvements within scope of responsibilities Stay current in the knowledge of global sanctions and regulatory requirements Collaborate and consult with associates on all levels Lead, participate in and provide support for projects and initiatives Required Qualifications: 4 + experience in Financial Crimes - AML -KYC, Sanctions Screening (Account and Transaction) or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education Desired Qualifications: Anti -Money Laundering (AML) Bank Secrecy Act (BSA) experience including strong knowledge and understanding of transaction monitoring.In-depth knowledge of OFAC regulations, US sanctions and global regulatory guidelinesGood analytical skills with high attention to detail and accuracy.Good verbal and written communication skills.Good time management skills and ability to meet deadlines.Microsoft Office (Word, Excel, and Outlook) skills

Job description Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Locations :-*Chennai *Mode Of Interview - Walk-In (*Call or Whtsapp Now our HR Specialist:- @ puja - 8250242229 for details) *Mode Of Work :- Work From Office * CTC Upto - 12 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) *Note:- *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app)

ql-editor "> Minimum Education: M. Pharmacy Technical competencies/ Professional expertise: Expert in regulatory activities like CTD dossier preparation, query solving, well worse with ICH guidelines and updated with current regulatory guidelines. Markets exp.: Predominately Africa market (Zazibona, South Africa, East Africa-Kenya, Tanzania, Ethiopia etc, FWA) Key Performance area: New Dossier Preparation and submission Gap analysis of dossier for completion Compilation of dossier in eCTD for submission to Various regulatory authorities Coordinate submission of dossiers in various countries Query Evaluation and Submission Receipt of the query letters from the respective country team Co-ordination with the manufacturer for the query response Review of the query response received from the manufacturer. Final compilation of query response and roll out to the respective countries Ensuring the deadlines. Post approval -lifecycle management of product (Variation) Receipt of the variation / renewal package from FPP manufacturer/ or initiation of variation from Innovata s end. Review of the variation package as per the variation guidelines of the respective country guidelines Co-ordination with the manufacturer. Final compilation of the variation package and roll out to respective countries Strictly monitoring harmonisation of dossier/queries/variation across all countries. Artworks Development of artworks and approval as SOP for queries and variations as applicable. Daily Communication Communication with internal (BD, marketing, logistics, legal, designing, country RA teams etc depts.) and external stake holders (manufacturing suppliers, country agents, vendors, consultants etc ). Updating of the trackers Updating of the trackers of queries and variations on regular basis Miscellaneous Attending unit and regional meetings, trainings, meetings with the manufacturers, telecons (internal and external stakeholders) Attending trainings identified by line manager organised by Intellectus Campus.

Role & responsibilities Reverse Engineering of Formulations: Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients . Utilize advanced analytical techniques for component identification and quantification. Analytical Method Development & Validation: Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies. Characterize excipients, degradation products, and impurities in formulations. Comparative Dissolution & Physicochemical Characterization: Conduct comparative dissolution profiling with RLD as per regulatory guidelines. Study particle size, polymorphism, stability, and compatibility of drug formulations. Regulatory Compliance & Documentation: Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions. Ensure compliance with ICH, USP, EP, JP, and WHO guidelines. Technology Transfer & Troubleshooting: Support technology transfer for scale-up and commercialization. Assist in troubleshooting analytical challenges during formulation development . Key Skills & Competencies: Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC Knowledge of polymorphism, solubility, permeability, and excipient compatibility Experience in reverse engineering & impurity profiling Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines Hands-on experience in GMP, GLP, and stability studies Preferred candidate profile M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry) Perks and benefits As Per Company Policy

*Process Management: Expertise in overseeing production processes, ensuring efficiency, compliance, and quality standards. *Production Planning & Scheduling: Ability to develop production plans that align with customer demand and business goals, optimizing resource utilization. *Leadership & Team Management: Proven track record in leading cross-functional teams, fostering collaboration, and driving high-performance cultures. *Regulatory Knowledge: Deep understanding of industry standards (GMP, FDA, EMA, ICH) and the ability to ensure compliance across all levels of production. *Quality Assurance: Strong focus on maintaining product quality, managing deviations, and implementing corrective and preventive actions (CAPA). Problem-Solving & Troubleshooting: Skilled at identifying issues in the manufacturing process, analyzing root causes, and implementing solutions quickly. *Process Optimization: Familiarity with Lean Manufacturing, Six Sigma, and other methodologies to improve operational efficiency and reduce costs. Equipment Maintenance & Management: Proficient in overseeing the upkeep, calibration, and validation of manufacturing equipment. *Safety & Compliance: In-depth knowledge of occupational health and safety standards, ensuring safe working environments.

Job Purpose Perform LHS-RHS activity with respective stakeholders including COEs, Business Compliance and horizontal support functions. Closely work with CDI and CMT teams within compliance. Validate and confirm closure of LHS-RHS response in compliance system. Duties and Responsibilities Major Activities carried out by the role 1.Major Activity 1 Perform LHS-RHS activity closed for all required circulars and guidelines issued by regulators. Create and execute annual LHS-RHS activity plan for all master circulars and guidelines. Work closely Businesses, COEs, Horizontal support functions for closure of LHS-RHS activity and become compliant for all guidelines issued by various regulators. 2.Major Activity 2 Engage and work closely with Businesses, COEs, Horizontal support functions to become compliant on all LHS points for various guidelines issued by regulators. Engage and work closely with sub functions within compliance unit (eg. CMT, CDI, advisory team etc) 3.Major Activity 3 Publishing reports on ICF activities Track and moderate closure of No items with respective stakeholders Key Decisions / Dimensions Prioritization of work and tasks as per situations and requirements -Co-ordination with stakeholders and submitting on various tool requirement. Major Challenges Complexity due to 99 PPG and compliance requirement -Maintaining timeline of LHS-RHS for multiple guidelines by multiple regulators (Majorly RBI along with IRDA, NPCI and UDAI. -Initial challenges with Compliance tool, as it is new and yet to be completely developed and maintained. -Very high expectation from the role. -New and big team Required Qualifications and Experience a)Qualifications CA / CS with 2-3 years experience in banking industry Additional certifications in banking and Compliance like CIA / CISA / CAIIB are preferred Strong domain knowledge of RBI requirements related to retail assets, liabilities, payments, etc in BFSI sector is required b)Work Experience 2 to 3 years of experience in Banking and finance industry in Compliance / operations / audit functions. Expertise in understanding of regulatory requirements specifically from RBI. Strong domain knowledge of RBI requirements related to retail assets, payments, etc in BFSI sector is required Relevant experience in content creation c)Skills Keywords Excellent communication skills and presentability Demonstrate leadership, negotiation, communication and audit/ compliance management skills in order to handle CDI team activities and engage with Senior Management Develop rapport with Business teams for adding value through compliance recommendations. Bring new knowledge on board and keep updated with rapidly changing business environment. Constantly challenge status quo for bringing value addition

Job Title: Business Risk & Control Analyst Role Description The team is part of the Team Business Risk & Controls (BRC). The PB BRC guards the Protect agenda by overseeing non-financial risks, conduct & control topics and regulatory changes. The team works across global PB franchise delivering complex key risk and control agenda, adding value for the Business to reduce complexity and enhance controls. The team works with cross-functional and global teams, collaborating with multiple stakeholders globally across the bank. Your key responsibilities Assist in designing and improving risk and control assessment processes in areas of responsibility Oversight/support in execution of non-financial risk topics including RCA topics Document and maintain various policies, manuals and internal procedures pertaining to non-Financial topics Support the production and delivery of monthly Non-Financial Risk materials, reports and MI at Global and Regional Level Develop subject matter expertise on non-financial risk and controls within the remit of the team Coordinate with a diverse set of stakeholders across 1LOD and 2LOD to help completion of NFR tasks and activities Support with implementation of new framework requirements wrt. to RCA process. Ensure that any sensitive issues are escalated promptly with sound analysis and recommendations Close cooperation with various BR&C stakeholders, primarily in Europe (focus: Germany) Your skills and experience Education & Experience: Strong knowledge of non-financial risks and controls Proven experience of working with risk and controls assessment processes Relevant experience in the Retail Banking / Private Banking sector or experience in financial services or consultancy (with Private Banking experience preferred but not essential) Experience working on small to medium scale projects within global environment. University degree Competencies: Very strong analytical skills (quantitative and qualitative) Proficiency with Microsoft Office programs; e.g. Excel , Word and PowerPoint Ability to work in crunch situations Strong work ethic, commitment to excel and proven capacity to work effectively with limited supervision Strong communication (written and verbal) and relationship skills Ability to clearly articulate and present supported topics Excellent command of the English language (written and spoken skills) Personal Characteristics: Proactive attitude and self-initiative Ability to think laterally. Strong Team Player skills as well as working independently Eagerness to learn and adapt to new situations and processes Delivery-focused, able to manage multiple deliverables to deadlines Flexibility with respect to new tasks and the ability to work diligently in stressful situations Ability to learn quickly Driven and able to handle day-to-day routine as well as cope with shifting priorities and changing responsibilities to meet needs and demands How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts throughout the bank A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

Key Responsibilities : Leverage in-depth knowledge of ICH, USP, EP, and IP guidelines to write and review developmental protocols and analytical reports. Participate in the ADL team, contributing to new method developments, method qualifications, and process development quality analysis for recombinant proteins and biosimilars. Conduct LC-based method development for quality evaluations, including techniques like RP-HPLC, Ion Exchange (IEX), and glycan analysis. Lead CE-based method development for quality assessments of recombinant proteins. Perform analytical tasks to support different stages of process development, from clone selection to upstream and downstream process optimizations. Undertake method qualifications and transfers, ensuring seamless transitions to manufacturing, quality control, or external laboratories. Plan and execute stability studies for R&D batches, assess stability trends, and provide insightful conclusions based on data analysis. Plan and manage experiments and day-to-day activities in the laboratory. Coordinate with external laboratories for outsourced analytical activities and ensure proper communication. Maintain detailed equipment logs, documentation, and ensure compliance with good laboratory practices (GLP). Compile and review experimental data, ensuring high-quality documentation. Qualifications and Experience : Masters degree in Biotechnology, Biochemistry, or Pharmaceutical Sciences, with a focus on biotechnology or related fields. 7-9 years of hands-on experience in analytical development for recombinant proteins (including mAbs and biosimilars). Strong knowledge and understanding of proteins, with expertise in LC-based analysis and method development. Experience working with ICH, USP, EP, and IP guidelines and protocols. In-depth knowledge of good laboratory practices (GLP). Strong team player with excellent written and verbal communication skills. Required Skills : Expertise in protein sample preparation techniques (centrifugation, concentration, extraction, etc.). Proficiency in the operation and troubleshooting of LC and CE systems. Experience with common laboratory instruments (e.g., UV-Vis Spectrometer, weighing balances). Strong analytical thinking and data evaluation skills, with a solid understanding of statistical methods. Proficiency in using MS Office tools for documentation and data analysis. Commitment to maintaining data integrity and adhering to good documentation practices. Key Competencies : Strong attention to detail and quality-focused mindset. Ability to collaborate effectively within cross-functional teams. Excellent organizational and time-management skills. Ability to independently plan and manage multiple experiments and tasks.

Project Role : Business Agility Practitioner Project Role Description : Professionals who provide business agility and technology innovation advisory services focused on organizational transformation in order to aid clients in outlearning and outperforming the competition. Must have skills : Computer System Validation (CSV) Good to have skills : Computer Vision Minimum 7.5 year(s) of experience is required Educational Qualification : Minimum 15 years of fulltime education Summary :As a Business Agility Practitioner, you will be responsible for providing advisory services focused on organizational transformation to aid clients in outlearning and outperforming the competition. Your typical day will involve utilizing your expertise in Computer System Validation (CSV) and Computer Vision to deliver impactful data-driven solutions. Roles & Responsibilities: Lead the development and implementation of Computer System Validation (CSV) strategies and methodologies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and implement innovative solutions to improve business processes and drive organizational transformation. Provide advisory services to clients on technology innovation and business agility, leveraging your expertise in Computer System Validation (CSV) and Computer Vision. Develop and maintain strong relationships with clients, ensuring their needs are met and expectations are exceeded. Stay updated with the latest advancements in Computer System Validation (CSV) and Computer Vision, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Computer Vision. Strong understanding of regulatory requirements and compliance related to Computer System Validation (CSV). Experience in providing advisory services to clients on technology innovation and business agility. Excellent communication and interpersonal skills to develop and maintain strong relationships with clients. Ability to stay updated with the latest advancements in Computer System Validation (CSV) and Computer Vision. Additional Information: The candidate should have a minimum of 7.5 years of experience in Computer System Validation (CSV). The ideal candidate will possess a strong educational background in computer science, engineering, or a related field, along with a proven track record of delivering impactful data-driven solutions. This position is based at our Bengaluru office. Qualifications Minimum 15 years of fulltime education

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years Language - Ability: Japanese - Elementary What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Collaboration and interpersonal skills Commitment to quality Ability to perform under pressure Prioritization of workload Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Any Graduation

The Contract Manager is a direct client-facing role responsible for both pre-award contract negotiations and post-award contract management. This role requires strong analytical, negotiation, and stakeholder management skills to ensure contractual obligations are met while optimizing business outcomes. Key Responsibilities: Lead pre-award contract negotiations, ensuring alignment with business objectives and legal compliance. Manage post-award contract execution, including tracking deliverables, mitigating risks, and ensuring compliance. Collaborate with cross-functional teams, including legal, procurement, finance, and operations, to drive contract efficiencies. Interpret complex contract terms and conditions and provide guidance to internal stakeholders. Monitor contract performance and proactively address potential issues. Maintain accurate records of contract correspondence, amendments, and renewals. Lead and mentor a team, aligning individual contributions with organizational strategy. Support squad leadership initiatives and drive engagement across teams. Required education Bachelor's Degree Required technical and professional expertise Bachelor's degree in Business, Law, Finance, or a related field. 15+ years of experience in contract management, negotiation, and administration. Strong understanding of contract law, regulatory requirements, and compliance standards. Proven ability to manage complex contracts and vendor agreements. Excellent negotiation and stakeholder management skills. Strong analytical and problem-solving capabilities. Effective communication and interpersonal skills. Experience in a shared services or enterprise enablement environment is a plus. Preferred technical and professional experience Certification in contract management (e.g., IACCM, CPCM, or equivalent). Experience in managing IT or technology-related contracts. Familiarity with IBM’s contract frameworks and enterprise solutions.

Job Title Payments - GPP Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements

Job Title Payments - GPP Responsibilities Global Pay Plus - Payments Technical and Professional Requirements: Payments:ISO-20022 standards SWIFT, SEPA, MT messages Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements