115 Cmc Jobs - Page 3

The RA CMC 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 Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal 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 management . Key Responsibilities Include: Generate 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 Knowledge and Skills CMC- specific regulatory knowledge & experience 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

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Responsibilities: Work with the regional RA team to prepare documents for the registration of OTC drugs and cosmetic products in non-EU countries. Provide regulatory support for select projects such as artwork maintenance and artwork support for legal department and other special projects on an as needed basis using a variety of systems internally Preparation and compilation of regulatory documentation for the registration and renewal of OTC drugs and cosmetic products for EMEA and local pool Support product registration in all EMEA regions including Nordics and Northern Cluster Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing Work with Kenvue regional Skin Health & Essential Health regulatory team and/or Provider Project Manager to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Creation of regulatory documents, e.g., ingredient list, regulatory clearance Manage all EU and UK cosmetics notifications Regulatory review of product specification and labeling Support Claim Table and MasterText creation Regulatory review of raw materials Regulatory review of materials change Regulatory review of formula composition Work with Kenvue cross functional partners to provide regulatory inputs for documents Regulatory review of product information file Prepare registration dossiers using regional data and liaising with manufacturing sites Support Kenvue local market contacts in their registration procedure as well as retrieving documents from APRs/GCCs Manage all cosmetic and femcare GCCs Complete market impact assessments Portfolio survey (where used of ingredients) Deliverables: Provision of weekly updates (at a minimum) to relevant Kenvue colleagues or Provider Project Manager Training off-shore colleagues with respect to raw material and formulation review and approval as well as ingredient list generation Ensuring that regulatory standards and timelines are met Creation and update of working practices for processes used between Outsource partner and North America Regulatory Affairs for Consumer products, using lessons learned approach Planning and tracking the status of ongoing regulatory projects Ensure that standards and timelines are met Use of regulatory database (RegPoint) and IT tools (GSS, CAPRI, Concerto, ArtWorks, Veracity etc.) Create and update working practices for processes used between Outsource partner and EMEA Regulatory Affairs, using lessons learned approach Plan and track resource levels required and used for regulatory support requested. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of two years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 13 yrs Work Location :Bangalore/Hyderabad/Pune/Chennai/Kolkata Required Skills, SAP BODS Interested candidates can send resumes to nandhini.spstaffing@gmail.com

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 6 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :5 to 8 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.

As a CMC RA Reg Manager, you will project manage global CMC regulatory submissions, ensuring that all project activities and documentation meet the required standards throughout the product lifecycle. You will lead and contribute to regulatory CMC components of business-related projects, maintaining effective communication with stakeholders and project team members to ensure timelines and regulatory commitments are met. Your expertise will help apply global CMC regulations and guidance within AstraZeneca, contributing to the development of new policies and processes. Accountabilities Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorization applications, and post-approval activities. Deliver submission ready CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality. Ensure publishing tools are in place and perform timely publishing of the CMC sections. Lead/represent PT&D and Pharm Sci on cross-functional work streams. Document maintenance and communication of Health Authority approval status. Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions. Adapt to changing situations to ensure on-time delivery through project management expertise. Proactively share learning from own projects with colleagues. Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) when applicable, advising project teams. Provide advice, training, and mentorship to other team members. Train others in procedures and practices relating to ANGEL within PT&D and Pharm Sci. Raise change requests (ANGEL), manage, escalate, and input into the cross-functional vote. Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence to optimize proposed submission content. Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team. Contribute to business process optimization activities to reduce waste and ensure efficiency. Evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments. Apply GxP principles according to the stage of the product lifecycle. Lead change as assigned. Understand the application of appropriate risk management across own activities. Demonstrate research skills in understanding regulations and mentorship from different regulatory agencies. Conduct activities and interactions consistent with Things We Value and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance. Essential Skills/Experience: Bachelors degree in Science, Regulatory Sciences or Pharmacy Breadth of knowledge of manufacturing, project, technical, and regulatory management IT Skills Partner & Project management Professional capabilities: Regulatory knowledge Desirable Skills/Experience: Masters degree in Science, Regulatory Sciences or Pharmacy Knowledge of the drug development process and regulatory submissions Understanding of current regulatory CMC requirements Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or sophisticated biologic products Understanding of regulations and mentorship governing the manufacture of biotechnology products, especially monoclonal antibodies Lean capabilities

Obtain and manage CMC-related documents for regulatory submissions. Ensure compliance with ICH, FDA, EMA, WHO, and other regulatory guidelines. Collaborate with internal teams and CMOs to prepare high-quality regulatory sections. Lead responses to CMC-related questions from regulatory authorities. Establish strategies for document authoring and quality. Implement industry standards for regulatory submissions. Communicate unified regulatory messages at interdisciplinary meetings. Identify and mitigate regulatory CMC risks. Promote continuous improvement within regulatory compliance. Ensure efficient and transparent working environment within GRA. Other tasks as required by senior management. Job Requirements: Bachelor s or master s degree in biotechnology, Life Sciences. 5+ years direct industry experience in Regulatory CMC Biologics, 10+ years industry-relevant experience. Hands-on experience with EMA/FDA/PMDA/Health Canada CTD requirements. Proven ability to produce high-quality CMC documentation for complex large molecules. Knowledge of CMC expectations at all stages of product development. Experience with post-market activities in the LCM space preferred. Strong communication and interpersonal skills. Ability to work independently and prioritize tasks effectively. Proficiency in English, written and spoken. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.

Hi We are Hiring for the job role of Medical Writer Job Description: * Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. * Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. * Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. * To work in coordination with all the members in the study team- internal and external for the development of clinical documents. * Share project timelines amongst the study team for the development of document. * Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. * Review statistical analysis plans and table/figure/listing, when required. * Ensure uniformity and consistency in the scientific content of the regulatory documents * Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. * Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. * Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. * Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. * Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. * Plan and organize project and non-project meetings, as and when required To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writer Mumbai ( Job Code # 56) b) For Position in Pune Search : Medical Writer Pune ( Job Code # 57)

Urgent requirement for immediate joining B.E /ITI/DIPLOMA /AND ANY DEGREE 2015 TO 2024 Candidates can also apply Roles and Responsibilities To measure dimensions using Vernier, Micrometer & VMM & cmm machine. Should have Knowledge in SPC, 8D, read & understand engineering drawings , rejection analysis. Knowledge of ISO documents.we need experienced in electrical maintenance in 5years. 1. Planning and carrying out scheduled maintenance. 2. Responding to emergencies. 3. Repairing equipment and testing repairs. 4. Supervising contractors, and engineering and technical staff. ordering specialist components, fixtures or fittings. 5.Managing stocks of supplies andvg equipment. 6.Keeping records of faults and repairs 7. DIagnosing of electrical & electronics faults. 8. Basic knowledge of plc programming and trouble shooting. ReplyForward Add reaction Desired Candidate Profile Diploma/B.E in Mechanical engineering Experience - 0 to 10 years in Line inspection _ Quality - Manufacturing Industry Perks and Benefits Attractive salary for the effective Candidates.

Main purpose of the Job: To provide inputs and/or assist the Head Clinical Development in development of clinical programs across indications involving vaccine candidates. Provide inputs to all aspects of product development including, synopsis and protocol design, conduct of clinical trials, implementation and monitoring; as well as data interpretation and reporting. Role & responsibilities Support the Head - Clinical Development in Strategizing Clinical Development of investigational vaccines to move into early phase of clinical trials. Provides input and/or support the Head in the design, planning, initiation and completion of clinical trials. Coordinate with Preclinical, CMC/Quality and Clinical teams with respect to product development. Responsible for the preparation of study protocols, Clinical dossiers and other regulatory submissions including publications. Assist in the execution of the assigned clinical trial and/or clinical program in partnership with other line functions including medical associates, statisticians, trial managers where applicable. Attend appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events.

Job Description: Executive- Regulatory Affairs- ANDA -(US Market) Responsible for ANDA Submission Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions. Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation Support the maintenance of regulatory files. Strong knowledge of dossier preparation, compilation, and submission guidelines for various regions including Markets. Experience working on ANDAs, CTDs, injectables, Orals and other regulated products. If interested Kindly share your updated CV on khyati@bvrpc.com

- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

1)Experience in placements & corporate relations 2)Experience in career services 3)Experience in strategic planning & management Interested candidates kindly share your cv on jolly.joseph@jaipuria.ac.in

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.

Alvotech is looking to hire a Manager for Global Regulatory Affairs Life-Cycle Management (LCM) Chemistry, Manufacturing, and Controls (CMC). In this role, you will support life-cycle management of biosimilar products by developing regulatory strategies, representing the CMC regulatory team in cross-departmental projects, and ensuring unified regulatory advice. You will also identify and mitigate regulatory risks, manage high-quality documentation, participate in health authority interactions, and collaborate with external partners. Key Responsibilities: Assist in developing regulatory LCM CMC strategies. Represent CMC regulatory team in cross-functional teams. Communicate unified GRA-aligned messages at interdisciplinary meetings. Identify and mitigate product CMC regulatory risks. Assess and approve change controls for responsible products. Review and manage high-quality CMC documentation. Understand and apply ICH, FDA guidelines, GMP, and quality requirements. Participate in health authority interactions. Interface with external partners to support commercial success. Support development of regulatory excellence tools and processes. Ensure efficient and transparent working environment within GRA. Keep projects on track and within budget. Job Requirements: PhD (1-3 years), MS (4-6 years), BS (6-8 years) in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities. Previous experience in life cycle management and variation filing for US, EU. Ability to work in matrix teams and diverse cultures. Ability to work effectively in a fast-paced dynamic environment. Fluency in English is essential; other languages are beneficial.

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead. 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 Manager 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 Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and support junior regulatory staff’s career development Identifies and implements process improvements for the change management process What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 10 to 12 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 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

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

The Senior Associate, Global Submission Management – International, 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 international (ex-US and Canada) 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 EU, JAPAC, GCC, ZA

What you will do Let’s do this. Let’s change the world. 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 submission execution for Amgen products across phases of development, modality, and countries. In this vital role you 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 submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket 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 submissions and related communications in the document management system Initiate and maintain CMC product 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development 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 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.

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in

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.