212 Cmc Jobs

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

The CT Scan Service Engineer will be responsible for installation, preventive and corrective maintenance, calibration, and troubleshooting of CT Scan equipment. The role ensures uptime, safety compliance, and smooth functioning of imaging equipment, while delivering technical support and service excellence to hospitals, diagnostic centers, and healthcare providers. Key Responsibilities: Install, configure, and test CT Scan machines as per manufacturer standards. Perform preventive maintenance, calibration, and performance checks to ensure equipment reliability. Diagnose and troubleshoot breakdowns, technical faults, and system errors. Coordinate with OEMs/vendors for spare parts, software upgrades, and technical escalations. Maintain accurate service records, maintenance schedules, and service reports. Ensure adherence to safety, regulatory, and compliance standards in healthcare environments. Provide training and technical guidance to hospital/diagnostic staff for optimal usage. Support service contract management, warranty claims, and AMC/CMC execution. Respond promptly to service calls and ensure minimum downtime of equipment. Required Skills & Competencies: Strong technical knowledge of CT Scan machines, X-ray systems, and related medical imaging equipment . Hands-on experience in troubleshooting, calibration, and maintenance . Knowledge of radiation safety standards and medical device regulations . Proficiency in using diagnostic tools, service manuals, and software. Good communication and client-handling skills. Ability to work independently and manage service calls efficiently. Educational Qualification: Diploma / B.Tech / B.E. in Biomedical Engineering, Electronics, or Instrumentation (or relevant discipline).

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination :- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements Reporting & Maintenance :- Maintain regulatory files/database

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

Experience : Experience with public health delivery system, research. Job Description : The call is for technical field level support to implement an ICMR project that aims to improve lifestyle in rural communities through self-help groups or volunteers in the village. The project activities involve facilitating the volunteers to mobilize the community for lifestyle modification and follow up persons with non-communicable diseases. The community managers are expected to liaise with the community, the self-help group members and the research team for implementation of the activities. Nature of Job : Term contract appointment for project implementation. Job condition : Community-based project in rural villages of Gudipala mandal, Chittoor, Andhra Pradesh. Job Preference : Fluency in Telugu and Tamil is required and will be given preference. Experience in community engagement process and community health promotion will be given preference. Note : Only Regular mode will be accepted, Private or correspondence will be not accepted.

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 CMCspecific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience Show more Show less

Experience in Regulatory affairs. Exp in CMC and Labeling. Location: Bachupally, Hyderabad.

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. Insights & Analytics ZSs Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership. Supply Chain - Chemistry Manufacturing & Controls ZS is looking to hire a Decision Analytics Consultant in ZS Supply Chain and Manufacturing practice with experience in pharmaceutical drug development and tech transfer. The primary responsibility of this role is to deliver projects in the pharmaceutical CMC development area for ZS clients. This includes serving as a subject matter expert on drug substance and drug product manufacturing in client discussions, managing teams and projects, and contributing to Supply Chain and Manufacturing practice development. What You ll Do Leverage quantitative skills to derive answers to clients ongoing business analytics and reporting questions Work collaboratively with client to ascertain the clients specific business information needs Upskill on concepts relevant to solve client problems across modalities Discuss and determine with clients which specific data may be best utilized in order to perform the necessary analysis Evaluate, assess and analyze the data necessary to provide solutions to the clients particular business information needs Communicate the data results to the client, with an emphasis on answering the business question as opposed to the analytical and reporting processes used Gain immediate familiarity with clients internal processes Develop expertise within a client analytics area Be available for clients during regular working hours What You ll Bring Bachelors (and often graduate) degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biotechnology or similar degree 6-8 years of experience working in a pharmaceutical CMC organization Hands-on experience with at least one of the functions in CMC development such as Process Chemistry, Process Engineering, Formulation, and Analytical Chemistry Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development Understanding of the different data and information systems such as ELN, LIMS, ERP systems, and LCM or PLM systems Understanding of the CMC related regulatory submission requirements Ability to translate the knowledge of concept in one modality to other modalities, if needed Experience presenting to senior leaders, executives, and audiences with CMC backgrounds Hands-on experience with data analytics with ability to generate insights from data from various sources Ability to lead multiple workstreams and demonstrate effective time and project management skills Experience with at least one tech transfer, exposure to analytics, AI and/or technology implementation in CMC preferred Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying? At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

All Tech M Location (Hybrid) - 12+ Years of Security implementation/support experience - Should be expert in ECC security (SU24 setups, end to end role build & other troubleshooting skills) - Should be proficient in BW security (Analysis Authorization based access provisioning) Good to have: - SAC, BTP, IBP knowledge - GRC Support knowledge - CRM, Fiori, CMC, BODS/BOBJ Security 1042867_TechM180087

Role & responsibilities Minimum of 10 years of Life Science industry experience, with substantial exposure to regulatory affairs. Hands on experience and demonstrated expertise in Chemistry, Manufacturing, and labeling processing Comprehensive understanding of global regulatory framework, including FDA, EMA, ICH and other international standards. Excellent communication skills both written and verbal Meticulous attention to detail and organizational prowess Proficiency in project management and cross-functional collaboration Strong analytical and problem-solving skills Ability to navigate and interpret complex regulatory landscapes across multiple regions Good understanding of Quality Management Systems in the outsourcing scenarios Must have skill set CMC labeling process global regulatory frameworks Good Clinical Practice Quality Management FDAEMA ICH Location: Pune, Chennai, Delhi, Bangalore, Kolkata, Hyderabad, Gurgaon Contact Person: Maheshwari Balasubramanian Email ID: maheshwari@gojobs.biz

Min 6yrs of experince in Regulatory affairs, CMC. US market exp must location Bachupally, Hyderabad

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination :- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements Reporting & Maintenance :- Maintain regulatory files/database

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.

Designation Field Service Engineer Department Service Location Kolhapur,Pune Product Portfolio IVD (In-Vitro Diagnostics) Business Importance of the Role: This role owns delivering service & service business results as per Operational Metrics defined below & meets the operating Business Plan of Genworks. Manages high level of Customer satisfaction through Service Excellence at assigned customer accounts/IB by driving various Operations parameters as per target. Also drive Commercial excellence through AMCs, CMCs, Part Sales, Accessories & Consumable Business time to time. Over a period of time becomes the Customer success leader & be the Point of contact by building strong relationship between Genworks & respective OEM. Key Responsibilities to Deliver (Daily, Weekly, Monthly, Quarterly, Annual): Timely installation, Troubleshooting and Calibration Pre-installation demos, checks and user maintenance training for instruments including primary level of application issues and standardisation handling. Troubleshoot Instrument related issues (break fix issues). Strive for customer success through solutions-based growth approach.

Supervise installation by client, commissioning, training and handover of air compressors & accessories. Maintenance of air compressors through PM, AMC, health check, etc. Problem identification and troubleshooting at customer location. Required Candidate profile Work Experience: 5-10 years of field experience in servicing of industrial machinery or utility department viz. air compressors, generators, blowers, process chillers, electric motors.

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficiency responses and/or post-approval submissions for above markets. Worked on various dosage forms including complex generics. Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections. Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections. Hands on experiance for ECTD compilation. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Masters Graduation in Pharmacy or Science

Role SAP BI/BW +BOBJ Senior Consultant Hiring Location: India (Delhi, Noida, Mumbai, Hyderabad) Responsibilities Document all technical and functional specifications for implemented solutions. Proficient in BW/B4H & ABAP/CDS with experience in the areas of Analysis, Design, Development Collaborate with clients to gather business requirements and translate them into BI/BW technical solutions. Interact with key stakeholders/support members in different areas of BW. Provide technical solutions to fulfil business requests using SAPs BW. Design, develop, configure, migrate, test and implement SAP BW 7.x data warehousing solutions using SAP BW, BW/4HANA, and related tools. Ensure data accuracy, integrity, and consistency in the SAP landscape. Optimize performance of queries, reports, and data models for better efficiency. Manage delivery of services against agreed SLAs as well as manage escalations both internal and externally. Understands client business requirements, processes, objectives and possesses the ability to develop necessary product adjustments to fulfil clients' needs. Develop process chains to load and monitor data loading. Provide technical guidance and mentorship to junior consultants and team members. Interact with key stakeholders/support members in different areas of BW. Design and build data flows including Info Objects, Advanced Datastore Objects (ADSO),Composite Providers, Transformations, DTPs and Data Sources Conduct requirement gathering sessions and provide design thinking approach. Develop process chains to load and monitor data loading. Work closely with clients to understand their business needs and provide tailored solutions. Build and maintain strong relationships with key stakeholders, ensuring satisfaction and trust. Manage and mentor a team of consultants, ensuring high-quality delivery and skill development. Facilitate knowledge sharing and promote the adoption of new tools and methodologies within the team. Act as an escalation point for technical and functional challenges. Well experience in handling P1 and P2 situations. Skills & Qualifications Bachelors Degree IT or equivalent 6 to 9 years of experience in one or more SAP modules. At least four full life cycle SAP BW implementation and at least two with BI 7.x experience (from Blueprint/Explore through Go-Live). Ability to use Service Marketplace to create tickets, research notes, review release notes and solution roadmaps as well as provide guidance to customers on release strategy. Exposure to other SAP modules and integration points. Strong understanding of SAP BW architecture, including BW on HANA, BW/4HANA, and SAP S/4HANA integration. Knowledge of SAP ECC, S/4HANA, and other SAP modules. Proficiency in SAP BI tools such as SAP BusinessObjects, SAP Lumira, and SAP Analytics Cloud. Experience with data modelling, ETL processes, and SQL. Certifications in SAP Certified Application Associate - SAP Business Warehouse (BW), SAP Certified Application Associate - SAP HANA. Should be well versed to get the data through different extraction methods. Flexible to work in shifts based on the project requirement. Strong skills in SAP BI/BW, BW/4HANA and BW on HANA development and production support experience. Excellent communication, client management, and stakeholder engagement abilities. Extensively worked on BW user exits, start routines, end routines with expertise in ABAP/4. Extensively worked on standard data source enhancements and info provider enhancements. In-depth knowledge and understanding of SAP BI Tools such as: Web Intelligence, Analysis for Office, Query Designer. Has end-to-end experience: can independently investigate issues from Data Source/Extractor to BI Report level problem solving skills. Has end-to-end Development experience: can build extractors, model within SAP BW, and develop Reporting solutions, including troubleshooting development issues.

As a Customer Service Associate at Accenture, you will be part of the Healthcare Management team responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. Your role will involve overseeing day-to-day operations, department activities, medical and health services, budgeting, research, education, policies, quality assurance, patient services, and public relations. Your primary responsibility will be to coordinate essential documentation and resources necessary for the filing of global applications related to healthcare operations. This will involve understanding, managing, and processing electronic submissions such as original application filings, Life Cycle Management submissions (e.g., CMC, Ad-promos, amendments, annual reports, SPL submissions), and more. In this position, you will be expected to solve routine problems using established guidelines and precedents. Your interactions will mainly be within your team and with your direct supervisor. You will receive detailed to moderate instruction on daily tasks and new assignments, with the decisions you make impacting your own work. As an individual contributor within a team, you will have a focused scope of work and may be required to work in rotational shifts. To qualify for this role, you should have at least 1 to 3 years of experience and hold a degree in Any Graduation. Join Accenture, a global professional services company at the forefront of digital, cloud, and security solutions. With a team of over 699,000 professionals serving clients in more than 120 countries, Accenture empowers change to drive value and success for clients, employees, partners, and communities. Visit www.accenture.com to learn more about our innovative services and career opportunities.,

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsYou will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Career Category Information Systems Job Description 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. .

Christian Medical College is looking for LIBRARY ASSISTANT to join our dynamic team and embark on a rewarding career journey Assist patrons in locating library materials, including books, journals, multimedia resources, and electronic databases Provide friendly and knowledgeable customer service by answering inquiries, assisting with library technology, and providing basic research assistance Check library materials in and out using the library's automated system, ensuring accuracy and maintaining patron confidentiality Shelving and organizing library materials according to established classification systems, ensuring items are easily accessible to patrons Process new library materials, including cataloging, labeling, and adding them to the library's collection Assist with the maintenance and upkeep of the library's physical space, including shelf tidiness, signage, and overall cleanliness Assist with interlibrary loan services, coordinating the borrowing and lending of materials with other libraries Conduct routine inventory checks to ensure the accuracy and availability of library materials Assist with library programs and events, such as storytime sessions, workshops, or book clubs, by setting up equipment, organizing materials, and providing logistical support Assist patrons with using library equipment, such as computers, printers, scanners, and audiovisual equipment Stay updated with library policies, procedures, and resources to provide accurate and up-to-date information to patrons Collaborate with other library staff members on projects and initiatives to enhance library services Perform basic administrative tasks, such as maintaining records, compiling statistics, and assisting with library reports

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. Formulate US regulatory filing strategy for new projects. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team. Good interpretation skill for ICH and FDA guidelines

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements. Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions. Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions. Implement and in some cases interpret global regulations and guidance s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements. Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and manage communications between Regional Submission Associate, GRA-CMC scientists, RD&E specialists and Quality/Regulatory representatives.

Career Category Regulatory Job Description Job Description: 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, R egulatory O ptimization o f T actical and S trategic S upport (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 Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions Preparing 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 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 procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science 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 .

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