PPIC, MS&T, Formulation development

• Creation and revision of Master documents: Specification, Standard Operating Procedure and General Procedures. • Implementation of Pharmacopeial Updates and Source Change Document. • Managing master data operations within the LIMS and SAP system.

• Site analytical testing , evaluation and Development • Implementation of Pharmacopeial Updates and Source Change Document. • Managing master data operations within the LIMS and SAP system. • Developing, Optimizing, Validating, Verifying and Method transfer of analytical methods. • Ensuring discipline in Track Wise by monitoring pending tasks and facilitating the closure of quality events. • Ensuring adherence to regulations and maintaining the completeness of relevant logbooks or registers.

Designing the developmental strategies for assigned products Perform feasibility assessment of new projects. Collation of developmental data for justifying the product requirements Assigning the daily activities to the team to meet the timelines of the project Co-ordinate with the analytical development to ensure the availability of development data Co-ordinate with sourcing department for the timely availability of materials for progress of the development activities. Co-ordinate with licensing department for the availability of licenses for submission batches. Co-ordinate with technology transfer/manufacturing department for smooth transfer of new products from Research and development to commercialization. Responsible for addressing regulatory deficiencies in co-ordination with cross functional teams. Preparation, approval & implementation of SOPs and relevant training activities & records. Calibration and qualification of equipment and instruments of Formulation Development Department. Ensure the compliance to the laid down systems and procedures by the team members. Ensure that the team members follow Good Documentation Practices, Quality Management systems such as Change control, deviations for continuous compliance. Responsible for designing experimental design (DoE) – composition and process optimization, statistical analysis, defining design space, statistical data interpretation and report preparation. Responsible for preparation of PDP and PDR.

1. Documentation related activities for Site Transfer Projects:- a. Teck pack evaluation for external site transfer projects and creation and approval of Techpack Index. b. Freezing of item codes for site transfer projects. c. Item code creation and approval - Raw materials and Semi Finished Goods (SFG) code creation and Creation of Finished Goods (FG) code for Exhibit batch for specific manufacturing location d. Preparation of stability protocols for Site transfer project of specific manufacturing location. e. Purchase Requisition (PR) initiation for Trial, PO, EB and VB batches and service PR for PDE and OEL reports.. 2.Drafting/Review and approval of Master Formula Records (MFR’s) for Site transfer projects 3. Revision / Review / Approval of Commercial Site transfer MFR’s (Including AVD code inclusion) 4. Drafting / Review / Approval of MES MFR’s and Handling of application interface of SAP and PLM 5. Handling of MQC/MIC updation and review. 6. Initiation, review & approval of Change Orders for updation of material master specifically for Site transfer codes. 7. Handling the SOP revision. 8. Approval of Artworks in OAMS related to first commercial batches of site transfer projects. 9. Impact assessment of CC related to site transfer projects, Initiation of CC for updation of MFR.

Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities in Europe, UK. Lead the preparation, review, and submission of high-quality regulatory CMC documentation. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs). Monitor and interpret global regulatory requirements and industry trends related to CMC and life cycle management. Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations. Lead or support meetings and interactions with regulatory authorities, as required. Maintain awareness of and help implement changes related to product quality systems, quality investigations, risk assessments, and change controls. Represent Regulatory CMC in cross-functional teams and support regulatory strategy for product life cycle management plans.

Regulatory Strategy Development: Develop and execute regulatory strategies for launching products in Emerging markets (SEA, GCC, CIS & Latam), considering regional nuances and regulatory requirements. Stay updated on regulatory changes and assess their impact on product registrations and compliance strategies. Regulatory Submissions and Approvals: Lead the preparation, submission, and management of regulatory dossiers and applications to obtain timely approvals for product launches. Coordinate responses to regulatory queries and requests for additional information to expedite approval processes. Cross-functional Collaboration: Collaborate closely with internal and external stakeholders such as R&D, Quality Assurance, Legal, and Marketing to ensure regulatory requirements are integrated into product development and launch plans. Provide regulatory guidance and support to teams to resolve issues and mitigate risks. Compliance and Risk Management: Monitor regulatory compliance throughout the product lifecycle, including post-market surveillance and reporting obligations. Assess regulatory risks and develop mitigation strategies to ensure business continuity and compliance with regulations. Relationship Management: Establish and nurture strong relationships with regulatory authorities and agencies and customers in Emerging Markets. Represent the organization in regulatory meetings, negotiations, and discussions to influence regulatory outcomes beneficial to the company. Regulatory Intelligence and Training: Stay abreast of emerging trends, guidelines, and best practices in regulatory affairs relevant to Emerging Markets. Conduct training sessions for internal teams to enhance awareness and understanding of regulatory requirements and processes.

Walk-in Drive @ Chennai on 15th June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles across our Manufacturing facilities in Chennai & Pondicherry. Venue: Days Hotel by Wyndham Chennai OMR, 245/1, Rajiv Gandhi Salai, Chennai, Padur, Tamil Nadu-603103 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Chennai/Pondicherry Key Skills: HPLC, GC, UV, IR, KF, FTIR, Dissolution, LIMS, GLP Department: Quality Assurance Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: IPQA, QMS, BMR Review, BPR Review, Line Clearance, Change Control, Deviation, CAPA Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Chennai Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Bottle Packing Machines Department: Engineering Utility & Instrumentation Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Chennai Key Skills: Utility, Water System, HVAC, Chillers, AHU, Air Compressors, Cooling Tower, DG, LT & HT Panel, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

1. Ensure Compliance with all applicable Environment, Health and Safety (EHS) laws, regulations, and codes of practice. 2. Ensure that EHS risks are identified & assessed, that appropriate measures are in place to manage those risks & that resources are commensurate with level of risk. 3. To assess the performance of individual EHS programmes and the overall EHS framework to identify opportunities for improvement. 4. Training all employees and contractors in EHS. 5. Daily monitoring and compliance of Permit to work of both contractor & in-house (both Internal & External). 6. Maintaining of all safety gadgets like Fire Hydrant System, Chemical Spill Kit, Eye wash shower, First aid boxes, Fire extinguishers, Safety signages, Street lights, Emergency exits, Emergency siren, Fire suppression system, Employee EHS compliance. 7. ETP operation and Waste management compliance. 8. Industrial hygiene monitoring and its compliance. 9. Electrical safety compliance including machine safety in all service areas, manufacturing & utility. 10. Accident/incident, investigation and monitoring and its compliance. 11. Comply with ISO 14001:2015 and ISO 45001: 2018 requirements on all EHS aspects.

R&D trial batch execution & documentation Good knowledge on solid oral/Liquid oral dosage form

Job Description Commercial Operations Lead; To manage business operations, drive supply planning, and build strong customer relationship. This role is pivotal in ensuring smooth commercial operations and supporting key business objectives. Experience: 5–7 years in commercial operations in regulated markets preferred. Execution of budgets Develop and manage budgets, to ensure that business and financial goals are achieved Supply planning Coordinate with planning and other cross functional teams to effectively plan product supplies Prompt escalation of delays and roadblocks for effective issue resolution of orders and supplies Customer management Managing comprehensive order to cash and operational customer relationship management Regulatory Compliance Ensure compliance with regulatory requirements and industry standards throughout the supply and contract tenure. Collaboration Establish good working relationships with all customers as well as cross functional teams like manufacturing, SCM, finance, PDC, regulatory and logistics to drive business and financial objectives Performance Monitoring Measure and provide qualitative insights on forecast accuracy, DIFOT and suggest measures for improvement Timely reporting to Management on business, operational and financial performance. Role Highlights: Budget management and supply coordination Order-to-cash & customer relationship management Regulatory compliance and performance monitoring Cross-functional collaboration with SCM, Finance, Regulatory & more Pre-requisites Candidates having 5-7 years of commercial operations experience in regulated market is preferable Strong understanding of pharmaceutical business, regulations, industry trends and market dynamics Ability to work in a fast-paced environment and manage multiple priorities Excellent communication, negotiation, interpersonal and presentation skills Proficient use in Microsoft Excel, Power Point presentations and SAP

Drive new product launches with end-to-end ownership — from planning to execution. This role requires strategic coordination across R&D, Regulatory, Marketing, and Business Development to ensure successful, timely, and compliant product launches Role Highlights: Candidates having 5-8 years of experience in regulated markets is preferred (not mandatory) Strong understanding of pharmaceutical regulations, industry trends, and market dynamics Proficiency in SAP, project management tools and software (preferable but not mandatory) Ability to work in a fast-paced environment and manage multiple priorities Excellent communication, negotiation, interpersonal and presentation skills End-to-end launch management Budget execution and governance Strategic planning and performance tracking Strong coordination with R&D, Regulatory, Marketing & BD teams Experience: 5–8 years in regulated markets preferred

Creation and approval for purchase requisition. PR through SAP. Discussion with supply chain team for PO issuance and tracking the material till delivery. GRN of material in R&D. Coordination with plant store team for GRN of material at respective plant location. Coordination with respective plant quality assurance and quality control team for sampling and analysis of material. Raising store indent and coordination with respective plant for getting the required raw material/packing material at R&D on time. Transfer of raw material and packing material from R&D to plant. Handling logistic activity for material movement. Management of day store to ensure material availability for R&D uses on daily basis. Reconciliation and inventory management at R&D and various site location for R&D and MS&T material. Handling and clearance of non-moving and slow-moving inventory to avoid expiry & write off the material. To publish a weekly, fortnightly and monthly stock statement with anticipated risk of material expiry. Keep R&D store and day store in compliance state for audit readiness. Handling of internal/ external audit. Ensuring all raw material and packing material availability as per project integrated timeline and published project plan. Coordination with project management and technical team to ensure material planning on time. Forwarding invoices to Accounts and following the accounting status based on urgent requirements. Online stock issuance and consumption update in SAP. Candidate should have hand-on experience of quality system i.e., change control, deviation and CAPA.

Company: Strides Pharma Science Limited Department: QA/QC Profile: Executive Locations: Alathur/Puducherry Qualification: B. Pharma/ M. Pharma/ M.Sc. Chemistry Experience: 2 to 6 years

Company: Strides Pharma Science Limited Department: IPQA Profile: Executive Office Locations: Alathur Qualification: B. Pharmacy/ M. Pharmacy Experience: 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Company: Strides Pharma Science Limited Department: Quality Control Position: Executive Job Location: Alathur Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability

operation of Granulation, Coating, Compression and Filling machines. Prepare tablet & capsules as per BMR Maintain GMP documentation Ensuring daily cleaning activity, machine preventive maintenance as per schedule. Knowledge of GMP, SOPs Ability to work in shifts

Walk-in Drive @ Bangalore on 22nd June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Strides Pharma Science Ltd. (R&D office): 165/2, 3rd Main Road, Oppo. Kalyani Magnum Tech Park, JP Nagar 4th Phase, Bengaluru-560076 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Bangalore Key Skills: Analysis of Raw Material, Finished products, In Process, Stability Samples, for Capsules & Tablets with expertise in HPLC. Department: Formulation Development Experience: 4-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Sachet Filling line, Bottle Packing Machines. Department: Engineering Projects & Utility Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Installation, Commissioning, Equipment Qualification, DQ, IQ, OQ, PQ, Utility, Water System, HVAC, AHU, Chiller, Air Compressor, Cooling Tower, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

Company: Strides Pharma Science Limited Department: Quality Control Profile: Executive Locations: Bangalore Qualification: B. Pharma/ M. Pharma/ M.Sc. Chemistry Experience: 2 to 6 years Key skills: Analysis of Material / Product by referring current version of specification STP with relevant material code. Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage Log / LIMS. Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products Tests as per SOP/STP. Proper handling of chromatographic column used for analysis. Maintain data integrity and appropriate traceability

Experience in review and compile the registration and renewal dossiers as per Emerging markets. Review of master documents (PDP, PDR, AMV, MFR, MPR, Specifications, PVR, and Stability Protocols) and DMF. Experience of Handling post-approval changes for Emerging markets. (South Africa, Latam, SEA, GCC, CIS and African Countries).