ResponsibilitiesCapacity Planning & Capacity Effective Utilization and Mapping of the budget Production planning and scheduling Material planning and scheduling Campaign Planning Master data management Business Continuity – De risking Plan (OS to IH, IH to OS), AVD Plan Implementation Site Transfer- API & Intermediate APO cycle Run: DRP >> NPR>>RCCP >> MRP >> PR review & release. Stock allocation File updating and tracking the D vs C, C vs S. Demand Fidelity (Captive, Filling, Launch & Marketing) NPL, Filling & Query Batches Supply management SCM Process maturity - Norms Setting, Cost to Serve, Planning Master Data Controller Chronic Supply Issues Resolution (Captive & Market) Inventory optimization Data management and support for the S&OP process. Daily / Weekly MIS report review & take necessary action

ResponsibilitiesDevelop, document, and maintain end?to?end regulatory strategies for medical devices across the key markets, ensuring alignment with product technology, intended use, risk classification, and business objectives. Manage preparation, review, and submission of regulatory dossiers, including: 510(k), PMA, Medical Device License applications, CE marking submissions, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE) submissions ensuring accuracy, consistency, and regulatory compliance of all submissions. Maintain the dossiers by filing annual reports and manage post?approval submissions and Lead change impact assessments for Design modifications, Manufacturing and process changes, Supplier and raw material changes, labeling changes by accurately assessing and classifying the changes and prepare and manage change submissions and notifications to agencies. Provide regulatory input on Human factors and usability engineering and assess regulatory adequacy of design and development documentation, Device verification and validation etc. Review and assess preclinical testing data (bench, biocompatibility, electrical safety, EMC, etc.), Clinical investigation data and performance evidence and ensure clinical and preclinical data meet regional regulatory expectations and are appropriately aligned with device claims and intended use. Manage activities related to supplier qualification, CAPAs, complaint handling, product performance and audits Act as a regulatory point of contact and prepare and coordinate responses to regulatory authority questions, deficiencies, and follow?ups, with agencies Develop and execute engagement strategies with agencies, including Pre?Submission meetings, key regulatory questions, and incorporation of agency feedback into development and submission plans. Act as the regulatory strategy lead on cross?functional project teams, translating complex regulatory requirements into actionable development and execution plans. Communicate clearly (written and oral) internally (e.g., company personnel) and externally (e.g., regulatory agencies, auditors, vendors)Qualification & ExperienceBachelor’s degree in Life Sciences, Engineering, Biomedical Sciences, or related field Advanced technical degree (PhD, MBA) preferred Experience More than 15 years of progressive medical device regulatory experience Hands?on experience with: FDA submissions (510(k), PMA, IDE) EU MDR and CE marking Health Canada device licensing

Responsibilities Schedules, prioritizes and assigns projects [i.e. PLCM submissions and deficiency responses. Review of change control record assessment (CCR), supplier driven changes (SDC) & pre-CMC changes and other department-driven projects etc.] to Regulatory Affairs team members to ensure business timelines are met. Review and ensure that timely submission of post-launch variations applications of assigned projects. Handling of deficiencies received from Apotex Affiliates and/or customer and health regulatory agencies for post-launch variations. Ensure documents are of high-quality standard to ensure one cycle review from Regulatory authorities. Support reporting manager in identifying high performers within team and prepare their development plan. Review of databases and established trackers to ensure accuracy of information (Review checklist for PLCM submission /deficiency response deficiency tracker, submission spreadsheet etc.) Supervises work of direct reports, determining training requirements, performing regular performance reviews and executing development plans in co-ordination with Reporting Manager. Regular interactions with stakeholders to discuss on expectations, deliverables/priorities and provide solutions to regulatory issues and/or problems. Works with other functional areas to resolve issues related to regulatory submissions, compliance, and internal processes. Coaches, trains and provides guidance to other team members in the preparation of quality submissions and other functional tasks. Acts as a back-up for other team members and as a designate to the Reporting Manager, as required. Contributes and encourage team members towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.Qualification & ExperienceA Graduate/ Post graduate degree in Chemistry/Pharmacy/Scientific/business discipline or similar.  Knowledge, Skills and Abilities:  Candidate should have knowledge about Post approval changes submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets. Experience:  Should have minimum 11 years of regulatory affairs experience in US/CAN/EU/AUS-NZ/ROW markets.  Experience in CMC document writing and review. Minimum 4 years of experience in managing a team.

ResponsibilitiesPrepare, compile & review product quality (CMC) & other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance. Create and/or revise raw material and packaging specifications, and other associated documents. Coordinate and interact with cross functional teams/departments for evaluation/impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other product related changes. Support Financial Data Management, Business Plan file creation and maintenance, Supplier data management and PO creation as required. Support for creation and update of global labeling documents, QC and other associated activities for the labeling projects Support stability data evaluation & report preparation, dissolution profile evaluation etc. Perform literature survey and preparing of various regulatory documents in support of excipients, APIs and/or drug products. Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external department. Responsible for specifications setting/justification, ensuring the Quality level for Laboratory support, perform Computerized System Validation (CSV) and upgradation of existing systems/software. Seek guidance from other team members and manager as needed, and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance. Implement use of consistent, efficient, and quality processes to meet timelines and deliverables according to regulatory requirements standard operating procedures and maintain a culture of high customer services. Japanese language expert (minimum JLPT N3 certified professional) with experience in Japanese business email and client communication. Support Japanese regulatory and supplier correspondence, translations (Japanese ? English), and coordination with RA teams.

ResponsibilitiesMaintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review. Under management’s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience. Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance’s to understand and accurately assess change controls. When needed, train Associate I’s on internal processes, procedures, databases and trackers. Other projects and duties as required/assigned Qualification & ExperienceM. Pharma degree in RA/QA discipline, a plus. Minimum four years plus pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred. Basic computer skills such as Word, Excel and familiarity with the internet Ability to work independently and on teams Good verbal and written communication skills Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

ResponsibilitiesMaintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency Independently work on supplements, compile and publish for managements review. Take a proactive approach for more complex submissions and contact internal stakeholders (when needed) to gain further insight on any given supplement. Convey findings to management and incorporate any.all applicable information in the submission to ensure a quality and a right first time submission. Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers Other projects and duties as required/assigned. Process improvementQualification & ExperienceM. Pharma degree in RA/QA discipline, a plus. Minimum 5+ years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines Demonstrates the ability to evaluate regulatory documents and determine appropriate action.

ResponsibilitiesProvide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals. Develop the international regulatory strategy and contribute to Global regulatory plans. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support and advise on the local label strategy and alignment to cCDS/reference label. Build effective relationships and communication paths across global, regional, local and functional organizations. Enable efficiencies and seamless execution across the international countries. Contribute to process improvement projects, as assigned.Qualification & ExperienceDoctorate degree and 6 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience Education & Experience (Preferred) Degree and in-depth regulatory experience and/or related to the region. In-depth knowledge of regional countries legislation and regulations relating to medicinal products.

ResponsibilitiesGenerate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Qualification & ExpeirenceCMC- specific regulatory knowledge & experience Education & Experience (Basic) Bachelor’s degree and 8-13 years of directly related experience Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Responsibilities The Regulatory Affairs Specialist provides cross?specialty administrative, compliance, and quality reporting support for Radiology, Anesthesia, Emergency Medicine, Hospital Medicine, and additional service lines as assigned. Reporting to the Healthcare Quality Director, this role assists in organizing, auditing, and maintaining the company’s regulatory and quality programs—ensuring accuracy, compliance, and readiness for internal and external review.  The Regulatory Affairs Specialist plays a key role in auditing documentation and coding, preparing regulatory materials, updating internal resources, and supporting the operational execution of quality programs such as MIPS (Merit?Based Incentive Payment System). This position collaborates closely with Operations, Coding, and Business Intelligence  A current Certified Professional Coder (CPC) credential and three years of experience with the MIPS program is required. Qualification & Experience High school diploma or equivalent required; associate or bachelor’s degree preferred.  Current Certified Professional Coder (CPC) credential required.  Minimum of three years working with the MIPS program is required.  Minimum of two years administrative experience.  Familiarity with Radiology, Anesthesia, Emergency Medicine, or Hospital Medicine coding is a plus but not required.

Responsibilities Dossier Preparation & Submission: Compile and submit regulatory dossiers (CTD/ACTD/Country specific index formats) for product registrations in ROW markets. Coordinate with cross-functional teams to gather necessary documentation for submissions. Ensure timely submission of applications in accordance with country-specific regulatory guidelines. Document Review & Compliance Review technical documents, including batch records, specifications, analytical methods, and validation reports, to ensure accuracy and compliance. Assess and approve labeling, packaging materials. MOH Queries & Communication Act as the primary liaison with regulatory authorities, addressing queries and providing necessary clarifications. Prepare and submit responses to deficiency letters or requests for additional information in a timely manner. Qualification & ExperienceBachelors or Master’s degree in Pharmacy, Life Sciences, or a related field. 2–5 years of experience in regulatory affairs, specifically in dossier preparation and submissions for international markets. Proficiency in CTD/ACTD/ Country specific index formats and familiarity with regulatory requirements of ROW countries.