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.

Responsibilities               Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDAs/MAA/DCP/ANDS etc but not limited to these.Periodic tracking of evolving Global Regulatory updates and updating to team and implimentation of the new expectations of Global competent Regulatory Agencies and review of all relevant data inclusive of the Type II DMF/ASMF etc.Support the maintenance of regulatory files and databases, PLCM, ensuring accuracy and completeness of documentation.Collaborate with cross-functional teams, including Quality Assurance, R&D, and Manufacturing, to gather necessary information for regulatory submissions.Assist in the review of labeling and promotional materials to ensure compliance with regulatory standards.Participate in regulatory intelligence activities, including monitoring regulatory updates and communicating relevant information to internal stakeholders.Provide administrative support as needed, including organizing meetings, preparing meeting agendas, and documenting meeting minutes.Any other related duties as assigned by Project Leader                                            Qualification & Experience Currently enrolled in Master of Pharmacy degree program in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.Strong attention to detail and organizational skills.Excellent written and verbal communication skills.Ability to work independently and collaboratively in a fast-paced environment.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).Prior experience or coursework in regulatory affairs or the pharmaceutical industry is preferred.

ResponsibilitiesStrong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats. Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes Support regulatory strategy development for new products and markets Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data. Respond to queries and deficiency letters from regulatory authorities Maintain regulatory databases and track submission timelines and approvalsQualification & ExperienceGraduate : M.Pharm Experience Tenure : 2- 5 years of relevant experience

ResponsibilitiesTo coordinate with different departments i.e. Formulation development (FDD), Analytical development (ADD), Packaging development (PDD), Production, Engineering, Quality control, Quality Assurance, Supply chain, Business development, Project management and any other department for timely execution of New projects. To plan, monitor and support for execution of the trial batch, exhibit batch, scale up/characterization batch and process qualification batches To prepare and review new product documents like material requirement sheet, master formula card, bill of material, risk assessment reports, scale up protocol and reports, exhibit/ trial batch manufacturing record and exhibit protocols and reports etc To provide the regulatory response and technical justification To initiate the gate pass for sample transfer at various sites of Sun Pharmaceutical Industries Limited To prepare and review approve new launch documents i.e. material requisition sheet, product history, trial/ characterization protocol and report, batch manufacturing record, process qualification protocol and reports etc To share process knowledge to cross functional departments through presentation for smooth technology transfer To review and evaluate product history and process parameters for technical remediation and improvement of product robustness To prepare and review investigation report/Justification report, additional activity protocol, regulatory evaluation etcQualification & ExperienceGraduate : M.Pharm Experience Tenure : 2 – 5 years

ResponsibilitiesFunctions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU’s Business. Work is periodically reviewed by Team Lead. Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Prepares the CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans. Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions. Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities. May represent CMC during interactions with internal partners either directly or in conjunction with Team Lead. Resolve issues and manage regulatory risks within project teams. Makes decisions to resolve moderate problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership. Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

ResponsibilitiesContribute to project tasks and milestones, ensuring work is organized to meet deadlines. Learn and apply basic team effectiveness skills within the immediate work team. Make decisions within limited options to resolve basic problems, under the supervisor's direction. Work in a structured environment using established procedures, seeking guidance from colleagues as needed. Have your work regularly reviewed for technical judgment, completeness, and accuracy, relying on your supervisor's judgment. Play a pivotal role in transitioning products from research to manufacturing, leveraging technical skills to address challenges. Collaborate closely with pilot-plant and production departments to ensure smooth technology transfer. Conduct tests and measurements throughout production stages, troubleshooting process or equipment issues. Prepare and review scale-up protocols, technology transfer protocols, batch manufacturing records, batch packaging records, and bill of materials. Establish small-scale production processes, use scaled-down lab processes for troubleshooting and share knowledge through existing systems while following effective safety protocols. Quallification & ExperienceApplicant must have a bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience Demonstrated knowledge and experience with Good Manufacturing Practices and analytical techniques. 

ResponsibilitiesScientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps.  Preparation & review of ANDA/NDA Drug Substance Modules & related activities.  Preparation of project status & updates for discussion in next level.  Assessment of change controls & vendor notifications.  Technical writing of deficiency responses, modules & other scientific regulatory documents, as required.  Participation in project meetings, coordination with CFTs, good communication & coordination.  Supporting Europe & Canada market due diligence projects for Drug substance part, as required.  Knowledge of current regulatory guidelines is required.  Experience of complex APIs will add value.  Knowledge of using AI in routine work will add value.Qualification & ExpeirneceM.Sc. Chemistry or M.Pharm Experience: 8 -15 yrs

Responsibilities  Responsible for developing, executing, and maintaining the regulatory requirements for biologicals, as well as managing regulatory commitments  Stay abreast of regulatory agency regulations, directives, guidelines, and policies for biologicals that could impact product development, in order to assess approval pathways and identify potential issues  Ensure lifecycle management through the timely submission of annual reports, supplements, etc., to maintain product continuity.  Support the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity  Provide regulatory support, as needed, in product in-licensing/due diligence reviews, product divestments, and product withdrawals.  Manage the execution of regulatory documentation, including PIND/IND/IMPD/CTA, original BLA/MAA, agency background packages, and responses to health authority questions, in accordance with established business processes and systems.  Set and monitor submission timelines in collaboration with key stakeholders.  Coordinate with global manufacturing sites and integrate regulatory strategy across those sites.  Provide consistent support to cross-functional teams such as commercial and clinical teams.  Ensure communication with regulatory authorities is conducted in accordance with established departmental procedures.  As applicable, review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, upon receipt  Compiles, prepares, and reviews regulatory submissions to regulatory agencies, as applicable.  Conduct department-level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures.  Participate in the authoring and/or review of departmental procedures/guidance, as applicable. Qualification & Experience M-Pharm in pharmaceutical sciences /M.Tech – Biotechnology / MSc- Life sciences Required Experience And Skills  10-15 years of hands-on experience in regulatory affairs  This role needs a regulatory expert with hands on experience on regulatory activities for NDAs / BLAs, who has the management capability of leading a group of team members 

Responsibilities  Commercial product/ stability batches / exhibit batches / characterization Batches – Master Batch Manufacturing Record and Master Batch Packaging Record.  Risk Assessment, Process Validation protocol, Incident and Investigation report, action, compliance, and closure.  CAPA plan and closure.  Protocols and reports.  Internal Quality Audit/ Regulatory Quality Audit Compliance and closure.  Change, control, Standard Operating Procedure, Planned Modification.  Other quality documents including amendments. To assist the Plant head in Batch Manufacturing, Warehouse and controlling the functions related to General oral solid dosage department. To plan and execute the schedule as per work plan. To ensure the achievement of Production and Warehouse output with respect to Quality and commercial demands.Qualification & ExperienceB.Pharm / M.Pharm Experience Tenure : 19+ Years (with recent USFDA experience & Wrap matrix molecules with Oros technology and Potent Molecules handling)

Responsibilities  Support global regulatory lifecycle management activities across EU, US, and international markets  Contribute to regulatory strategy development for global and regional submissions  Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5)  Manage post-approval changes, variation submissions, and follow-up activities  Handle Health Authority queries and ensure timely responses  Provide submission management support including planning, coordination, and timeline tracking  Maintain accurate records in Regulatory Information Management (RIM) systems  Support safety-related regulatory activities such as aggregate reports and urgent safety updates  Assist with audit, compliance, and inspection readiness activitiesQualification & Experience Strong knowledge of EU & US regulatory procedures and post-approval requirements  Experience in global submission management and lifecycle maintenance  Understanding of regulatory documentation and compliance standards  Strong coordination and stakeholder management skills.  2 to 4 years of relevant experience Educational Qualification  B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy