ResponsibilitiesLead end-to-end regulatory activities for innovative biological product portfolios across global markets (Emerging Markets).Develop and execute regulatory strategies aligned with business objectives and market requirements.Oversee preparation, review, and submission of dossiers (CTD/eCTD) including IND/IMPD/CTA, MAA, variations, amendments, and renewals.Act as the primary point of contact with country affiliates and global health authorities for regulatory interactions, queries, and inspections.Provide strategic guidance on regulatory pathways for biological products including clinical requirements of country of origin or single region clinical study data.Ensure compliance with evolving regulatory frameworks, guidelines, and quality standards.Collaborate with partners and cross-functional teams (R&D, Quality, Clinical, Medical, Manufacturing, commercial, marketing and supply Chain) to drive regulatory milestones.Identify risks in submission timelines and proactively implement mitigation plans.Qualification & Experience Advanced degree in Pharmacy, Biotechnology, or related field.Strong experience in Regulatory Affairs with exposure to biosimilars or biologicals.Proven experience in handling global submissions (ANVISA, SAHPRA, DIGIMED, TGA, MEDSAFE, COFEPRESS,USFDA, EMA, or other major agencies).Strong understanding of biosimilar regulatory frameworks and lifecycle management.Excellent communication, strategic thinking, and stakeholder management skills.Regulatory Strategy & ComplianceGlobal Stakeholder ManagementAnalytical & Problem-Solving SkillsStrong Execution & OwnershipEducational qualification: Post graduate in Pharmacy/ScienceMinimum work experience: 8+ years in Pharmaceutical Industry with 5 years of experience in global regulatory affairs.Experience in formulation development, analytical development and quality.Understanding of Good Manufacturing practice/Quality Systems.Understanding of product development, manufacturing processes, Intellectual Property and quality.Technical knowledge and understanding of the regulatory requirements of different dosage forms.Thorough understanding of regulatory guidelines for different countries, ICH guidelines, pharmacopeia's, product filing and approval requirements.

ResponsibilitiesShould be capable of leading the team towards QMS elements which includes handling of deviations, OOS, market complaints, CAPA management, Risk assessments, change controls, protocols, reports, discrepancies, batch and packaging records closures.Driving the improvement projects in the drug product.Should be leading the team for All time audit readiness and should be writing the responses to audit observations.Reviewing and approving SOPs, protocols, reports, discrepancies, change requests, CAPA (Corrective and Preventive Actions), QRM (Quality Risk Management), and batch and packaging records.Collaborating with cross-functional departments to close discrepancies and implement corrective actions, ensuring compliance with relevant GMP (Good Manufacturing Practices), safety standards, and SOPs for designated manufacturing equipment.Completing batch documentation in compliance with GMP, collecting and maintaining data, and participating/leading in quality and safety investigations to address and improve CAPA for drug product manufacturing.Engaging in continuous improvement activities, adhering to safety rules, and reporting any unsafe matters or near misses/accidents."Qualification & Experience Minimum 10+ years of experience with qualification in B.Pharmacy/M.Pharmacy/B.Tech/M.Tech biotechnology 

ResponsibilitiesBiobank OperationsManage end-to-end biobank activities including specimen collection, accessioning, processing, cataloguing, storage, retrieval, and distribution.Ensure specimen integrity through proper storage conditions, environmental monitoring, and temperature control.Maintain complete traceability of biological samples using Laboratory Information Management Systems (LIMS) or equivalent platforms.Ensure proper documentation and chain of custody for all biological specimens.Laboratory OperationsOversee day-to-day laboratory operations and ensure uninterrupted workflow.Manage preventive maintenance, calibration, validation, and troubleshooting of laboratory equipment.Coordinate with vendors for timely servicing and maintenance of laboratory infrastructure.Ensure laboratory equipment operates efficiently with minimal downtime.Quality & Regulatory ComplianceDevelop, implement, and periodically review Standard Operating Procedures (SOPs).Ensure compliance with GLP, GMP, GCP, NABL, FDA, HIPAA, GDPR, institutional policies, and applicable regulatory requirements.Lead internal audits and coordinate external inspections and accreditation activities.Ensure compliance with biosafety, biosecurity, hazardous material handling, and biomedical waste management guidelines.Inventory & DocumentationManage laboratory inventory, biological samples, reagents, consumables, and critical supplies.Maintain laboratory documentation, equipment logs, quality records, and audit documentation.Ensure data integrity, confidentiality, and secure management of research and patient-related information.Research CoordinationCollaborate with clinicians, researchers, Principal Investigators, and cross-functional teams to support research programs.Coordinate specimen logistics while ensuring compliance with approved research protocols.Support research initiatives by maintaining operational excellence within the laboratory.People ManagementTrain, mentor, and supervise laboratory and biobank personnel.Promote a culture of quality, safety, compliance, and continuous improvement.Monitor team performance and ensure adherence to laboratory standards and SOPs.Qualification & Experience   Strong knowledge of biobank operations and laboratory management.Experience with Laboratory Information Management Systems (LIMS).Thorough understanding of laboratory quality standards and regulatory guidelines.Knowledge of biosafety, biosecurity, and biomedical waste management.Excellent analytical, organizational, and documentation skills.Strong leadership, stakeholder management, and communication abilities.Ability to manage multiple priorities in a research-oriented environment.High level of integrity, attention to detail, and commitment to quality.Qualification : M.Sc./M.Tech./Ph.D. in Life Sciences, Biotechnology, Biomedical Sciences, Molecular Biology, or a related discipline.Certification in Quality Management Systems, Biosafety, or Laboratory Quality Management will be an added advantage.

Qualification & Experience  Pharm D/M.Sc. in Life Sciences/Clinical Research/BiotechnologyMinimum 4 Years of prior experience in an established Clinical Research wing.

Responsibilities Planning and Execution of all Microbial and mammalian upstream related processes and lab activities.  Designing and executing experiments for yield and Quality improvement and process intensification of current commercial microbial and mammalian products and protocol based batches execution.  An executive with extensive expertise in Biologics (Upstream) Development & Manufacturing: Product Technical Life Cycle Management.  Collaborate with cross-functional teams to facilitate the transfer of upstream processes from development to manufacturing.  Provide technical expertise in upstream bioprocessing, to optimize manufacturing processes.  Work closely with development teams to gather and document critical process parameters and data for successful transfer.  Collaborate with Quality Assurance to ensure compliance with cGMP and other regulatory standards.  Participate in process validation activities and support the resolution of deviations or discrepancies.Qualification & ExperienceEducation: Master’s in Biotechnology, or related field. Relevant professional / Educational background 3+ years in biopharma manufacturing in MSAT or process improvement roles.

ResponsibilitiesMethod development and qualification, characterisation of Lupin’s products and reference medicinal products Documentation related: Preparation and review of documents, data review Compliance related activities: CSV coordinator Instrument related: Equipment qualification, weighing balance performance coordination Maintenance: Maintenance of GLP, GDP and support, supervision and management Instrument maintenance: CD, SPR, Octet, FTIR, BLI, refrigerator and miscellaneous, equipment ID generation. Technolgy Transfer , Complaince with EHS and safety Qualification & Expeirnece5-6 years of experience in protein structure biology Education Masters in Biology or Biology Post Graduation in Biology or Biology

ResponsibilitiesAggregate Safety Reports & Documentation: Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) and any other ad hoc safety documents, ensuring scientific accuracy, regulatory compliance, and timely delivery. Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges. Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution. Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents such as but not limited to PBRERs, DSUR etc.). Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities, in accordance with agreed timelines, distribution lists, and email templates (as required). Safety Analysis & Signal Management: Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns. Provides expert interpretation of complex safety data patterns and trends across product lifecycles. Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team. Collaborates with cross-functional teams to analyze complex safety data and provide support as part of the study management team. Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents. Leads safety evaluations for complex molecules and sensitive indications, providing scientific direction that supports clinical strategy and strengthens regulatory positioning through high-quality safety reports and responses. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous.Strong analytical and problem-solving abilities, with the capability to independently evaluate complex data and draw meaningful conclusions. Exceptional communication skills, both verbal and written, including the ability to produce clear, concise, and accurate medical/scientific content. Excellent interpersonal and collaboration skills, fostering productive relationships with clients, cross-functional teams, and stakeholders. Effective organizational and prioritization skills, with the ability to manage multiple tasks enthusiastically and maintain attention to detail under tight timelines. Client-focused mindset, demonstrating flexibility, professionalism, and a proactive approach to meeting client expectations and expanding business opportunities. Strong negotiation and stakeholder management skills, ensuring alignment of resources, timelines, and deliverables across teams and departments. Cultural awareness and adaptability, enabling effective communication and collaboration in global, multicultural environments. Proficient in computer operations and IT tools, with expertise in web-based applications and familiarity with the Windows operating system and Microsoft Office suite (Word, Excel, PowerPoint). Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.:

ResponsibilitiesAggregate Safety Reports & Documentation: Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) Develops strategic approaches for challenging safety submissions, incorporating innovative data presentation techniques to enhance clarity and regulatory impact. Reviews and approves high-complexity safety documents, ensuring scientific accuracy, regulatory compliance, and alignment with product strategy. Coordinates multi-document submissions, ensuring consistency and integration across safety documentation packages. Provides expert guidance on evolving global regulatory requirements and advises on their implications for safety documentation. Manages meeting logistics including scheduling, agenda drafting, minute preparation, and tracking of action items, ensuring timely follow-up and resolution of open issues. Safety Analysis & Signal Management:Designs and implements advanced signal detection plans tailored to specific product profiles and diverse data sources. Leads signal detection for priority products by conducting expert-level analyses to uncover subtle safety signals and complex data patterns. Develops robust literature review strategies and critically evaluates complex scientific evidence or inclusion in PSRs, drug safety reports, and RMPs. Supports clinical safety and ad-hoc safety activities for complex molecules, contributing to strategic safety evaluations. Authors and reviews high-priority signal assessment reports and health authority response documents, resolves data challenges, and enhances decision-making through expert analysis and innovative visualizations. Risk Management Plan:Leads the preparation, updating, and integration of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) across multiple regulatory regions and product types, ensuring alignment with evolving safety profiles and strategic objectives. Prepares and handles reviews of health authority response documents, incorporating safety data and regulatory insights to address queries and support submissions of RMPs. Oversees Reference member state (RMS) updates, ensuring consistency with client conventions, global regulatory expectations, and internal SOPs. Provides strategic input on risk minimization measures and benefit-risk communication, tailoring content to diverse regulatory audiences. Collaborates with cross-functional teams to ensure RMPs are scientifically robust, compliant, and aligned with the overall safety strategy. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous. Demonstrates advanced analytical thinking and problem-solving skills to interpret complex safety data and derive meaningful conclusions to support benefit-risk assessments. Possesses strong scientific writing and communication capabilities, ensuring the production of clear, accurate, and regulatory-compliant documents. Strong capability to lead and collaborate across cross-functional, global teams and build trusted client relationships. Excels in organizational and time management, with the ability to prioritize tasks, manage multiple high-impact projects, and consistently meet deadlines. Proficient in medical writing tools and MS Office applications, with working knowledge of pharmacovigilance databases and coding dictionaries such as MedDRA and WHO-DD. Proactive in adopting new technologies, driving process improvements, and applying innovative approaches to safety documentation. Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.

Qualification & Experience M.Sc Biotechnology / Life sciences Skills required: Good analytical skills Good English language skills (oral and written) Knowledge of MS office

ResponsibilitiesEnsure that all maintenance activities are performed to a high standard. Develop and maintain a comprehensive inventory of all biomedical equipment and ensure that it is properly mapped, maintained and repaired as needed. Work closely with the backend engineering (DM& DI) team to understand the maintenance needs of the equipment and ensure that the system meets those requirements. Ensure that all maintenance activities are properly documented and that records are properly maintained (Mapping books, service reports). Collaborate with the Warehouse team to ensure that all necessary spares and equipment are available for maintenance activities. Stay up-to-date with new technologies and trends in the field of biomedical equipment maintenance. Provide technical support and guidance to other members of the biomedical engineering team. Qualification & Experience      Bio-Medical degree/diploma Thorough experience in Bio-Medical Deep Knowhow on the Bio-Medical equipments Experience- Mini.5 Years