115 Cmc Jobs - Page 2

Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills. Project Management. Regulatory Compliance. Risk Assessment. Risk Management. Languages : English.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Experience and Educational Requirements Several years experience, or demonstrable capability, in area of responsibility on similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks. University degree in Life Science. Minimum Skills, Knowledge and Ability Requirements Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures. Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision. Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-today working level as we'll as clients team lead level. Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance. English business fluent

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Experience and Educational Requirements Several years experience, or demonstrable capability, in area of responsibility on similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks. University degree in Life Science. Minimum Skills, Knowledge and Ability Requirements Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures. Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision. Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-today working level as we'll as clients team lead level. Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance. English business fluent

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.

Summary The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes. About the Role Major accountabilities: Performs strategic planning of more complex and/or accelerated projects with e.g., multiple candidates / scenarios, or of several projects with varying timescales. Has sense of urgency, aligns, and coordinates multiple activities in complex plans. Establishes realistic project timelines to achieve milestones and goals, organizes additional resources if needed to fulfill planning, tracks progress and takes actions if obstacles emerge or priorities change. Establishes technical development plans in line with priority classification of project, gated by clinical readouts as appropriate and with an enterprise view in consideration of overall portfolio priorities. Establishes high level summaries for presentation to management and stakeholders. Has advanced skill to identify, assess, manage, and communicate CMC risks / program risks. Due to seniority and experience, can handle more difficult risks, issues in more complex projects and handle multiple risks of DS/DP/Device even with junior CMC team members. Provides drug development expertise in addition to technical expertise. Follows standard process but at the same time thinks outside the box based on existing knowledge. Challenges the status quo, is curious and fosters creativity of team members and own creativity. Leverages existing knowledge and implements in EPT/GPT strategy. Continues to follow and stands behind EPT/GPT decisions. For complex late phase programs, Senior TPL supports defined work packages. Build relationships by identifying common interests and priorities with a variety of people inside and outside the organization. Has deeper understanding of current organizational structure, establishes networks and uses own network to resolve challenging situations and manage/drive change. Participates in boards and joins and/or can lead discussions in leadership teams. Is highly skilled in collaborative settings (i.e., external vs internal, CROs, DDs, in-/out-licensing settings). Approaches/analyzes issues and collaborates with other line functions for optimal solutions. Takes into account multiple stakeholder perspectives and approaches to find optimal solutions and build commitment and consensus. Provides knowledge of industry, main competitors, customers and external environment - this includes healthcare industry and global industry, digital and technological advancements. Shares knowledge with CMC community, e.g., by lessons learned sessions. Uses knowledge and experience to challenge and influence CMC line functions and/or EPTs/GPTs in background of the overall drug development strategy / industry insight. Actively contributes to EPTs/GPTs beyond CMC line functions. Is able to navigate and manage the complexity of the dis-ease area GPTs. Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure. Relates to people in an open, friendly, and accepting manner. Understands the formal and informal channels for exchange of ideas and provides constructive feedback. Reacts tactfully when receiving advice, instruction or critical feedback and openly gives and receives feedback. Remains calm and objective and demonstrates respect, composure, and professionalism during difficult circumstances, including difficult interpersonal situations. Learns to manage teams/stakeholders appropriately (utilizing their support). Brings forward sound proposals and shares lessons learned, without passing the blame. Anticipates setbacks and stays in control - takes criticism as intended for situations (not personally or toward particular individuals). Recovers quickly from problems and setbacks. Exhibits servant leadership and provides mentoring/coaching to junior TPLs, line functions and CMC team members to support their professional and personal growth. Leads by example and drives decisions. Minimum requirements Successfully demonstrated several years (minimum of 2-3 years) of directly related experience as functional project leader and relevant experience as Associate TPL or equivalent. Has strong scientific/technical knowledge, understands technical development tasks. Is able to establish/maintain DS/DP/Device supply plan (in alignment with CSPL). Has fundamental knowledge of GMP and regulatory requirements. Has fundamental cross-functional knowledge (PK/PD, tox, clinical, commercial) regarding drug development. Manages end to end technical drug development and knowledge. Completed basic project management training. Potential extension (not mandatory): Basic/Bronze IQP training. Is adept at using and regularly uses/updates project management tools available in TRD (e.g. Gantt charts, MS Project, Resource Cockpit). Knows fundamental IT tools. Has effective presentation skills.

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills. Project Management. Regulatory Compliance. Risk Assessment. Risk Management. Languages : English.

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills. Project Management. Regulatory Compliance. Risk Assessment. Risk Management. Languages : English.

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. As needed, coordinate /collect /store source documentation needed for direct submission to Health Authorities. Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality regulatory documentation -No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely accurate information / communication about project documentation specific issues within own department and to key stakeholders. RA CMC regulatory documentation follows Novartis guidelines meets regulatory guidelines. Builds maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Project Management. Operations Management and Execution. Collaborating across boundaries. Skills: Documentation Management. Lifesciences. Operational Excellence. Regulatory Compliance. Languages : English.

Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing Control). This applies to sector-specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements. Supporting change - and inspection management within the QA Compliance Team. Key Responsibilities: Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date. Conducting training to ensure appropriate knowledge and regulatory compliance. Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis products and customer products. Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle. Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits. Implementation and overview of initiatives to improve (regulatory) compliance. Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products. Essential Requirements: Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent. Fluent English (German desired). More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids. Ability to speak up and to take Quality decisions during challenging situations. Desirable Requirements: Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience. Ability to work independently and effectively in international, complex, and multifaceted environments.

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Career Category Regulatory Job Description The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master s degree OR Bachelor s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry .

Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Role & responsibilities :- Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc

The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new product developments and major CMC changes. Incumbent may oversee specific elements of internal compliance processes and ensure best practices are in place aligned to KPIs. The CMC Senior Manager may mentor a team of manager(s) and/or associate(s); in that case, he/she would have the overall accountability of the portfolio supported by the team. The CMC Senior Manager may be a Subject Matter Expert, bringing in the role and/or developing particular expertise in the regulations of a (set of) country/ies or on a specific field in CMC. In that role the CMC Senior Manager would be expected to provide guidance across the wider CMC team and to other functions in his/her field of expertise. Key Responsibilities Responsible for CMC regulatory matters and activities relating to new registrations and life-cycle maintenance for an assigned category portfolio of projects and products. Establishes and communicates global CMC regulatory strategy. Provide oversight/ mentorship for a portfolio and/or technical leadership on specific CMC topics Provides consistent input to project charters and plans, including Regulatory/CMC inputs into the business case for value engineering, approach, milestone plan and risk register for assigned products/projects. Works with Regulatory Category, Regional & PLM, product development, supply chain and tech excellence to assure alignment of registration strategy for all new or modified formulations and high quality of submission packages. Ensures regulatory requirements of the major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Leverages experience across regions for the allocated projects/products and provides regulatory CMC advice on a global basis. Provides CMC regulatory expert advice to the cross-functional teams including project and brand team(s) regarding new opportunity evaluations (including due diligence as required) and CMC requirements for new product development, registration and life-cycle maintenance. Interacts with other functions and Regulatory Category, Regional & PLM colleagues to deliver high quality CMC dossiers, documents and materials in accordance with business priorities (e.g. CMC sections of Briefing Books for HAs meetings, INDs/CTAs, NDAs/MAAs). Provides CMC supports to local Regulatory Affairs in interactions with local Regulatory Agencies and experts. May interact directly with local Regulatory Agencies via email, phone, or in-person meetings, depending on project/affiliate needs. Supports registrations, variations and renewals including responses to Regulatory Agency CMC questions. Participates on the Regulatory Expert Teams of Global and local Regulatory Affairs colleagues to develop and implement regulatory strategies (when required) for all countries in product scope. Ensures regulatory priorities of all major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of internal process records. Effectively communicates (technical) regulatory requirements and guidelines, ensuring timely and complete submissions. May act as a contributor to the Global Regulatory Intelligence team handling assigned responsibilities/regions (e.g. EU for EU based roles), potentially covering medicines, cosmetics, devices and foods. May oversee parts of the overall CMC compliance process, leading improvement projects ensuring KPIs are in place. May be involved in site or Notified Body audits when required. May contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments, projects and as subject matter expert (SME). Qualifications BA or BSc- Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering), RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP Position requires practically applied demonstration of intellect and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility 8 plus years experience in Regulatory Affairs, Quality & Manufacturing Product lifecycle support ensures compliance and requires regulatory strategy and filing of submissions at a global level. Oversight of the defined products requires a strong background in medicines, devices, cosmetics or dietary supplements. List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. .

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments 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 May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality, and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms