161 Fda Jobs - Page 3

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.

We are looking for Quality Head, who has worked at least 10years in SGI Casting speciality in Manhole cover division. Maintain QMS, with computer knowledge. Job location-Howrah(WB),Salary-35k-45k Monthly. Walk in Interview. Contact : +91 7687919790

Total Experience: 5+ Years Relevant Experience: 5+ Years Job Description: We are seeking a skilled and detail-oriented Senior QA Engineer with a strong background in the banking domain and hands-on expertise in mobile banking application testing . The ideal candidate will have proven experience working with tools and frameworks such as Aperio , FDA , Inteflow , and Signature systems, and a solid command of test automation using Selenium with Java . Roles and Responsibilities: Conduct comprehensive testing for mobile banking applications , including Loans, Accounts, and Credit Card modules. Work with banking platforms and tools such as Signature , Aperio , FDA , and Inteflow . Collaborate with cross-functional teams in Agile/Scrum delivery models . Analyze and assess requirements to determine test scope, perform test estimations, and develop detailed test plans and scripts. Execute functional, regression, and automation tests while managing defects efficiently. Ensure adherence to quality assurance processes and best practices throughout the testing lifecycle . Utilize JIRA, Zephyr, and Confluence for test case management, reporting, and documentation. Apply strong version control and collaboration practices using Git and an understanding of branching strategies . Contribute to continuous test process improvements and help establish best practices in test automation and QA delivery. Mandatory Skills: Banking Domain Expertise : Signature, Aperio, FDA, Inteflow Automation Testing : Selenium with Java Strong understanding of Loans, Accounts, and Credit Card functionalities in banking Test Management Tools: JIRA, Zephyr, Confluence Agile Methodologies and Scrum Practices Git and branching strategies Nice to Have: Exposure to API testing and mobile automation frameworks ISTQB or equivalent certification

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VALIDATION is MUST, preferably in Life Science . EXP in process optimization in automated test environment. GOOD knowledge in software development life cycle ( SDLC ). EXP in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guideline and FDA regulations on COMPUTER SYSTEM VALIDATION . Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICH and FDA. Coordinating multiple validation and qualification activities with project teams, various departments and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments. Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11 to client personnel. Representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/https://g.co/kgs/UAsF9W

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Roles and Responsibilities Manage regulatory affairs for domestic and international markets, ensuring compliance with FDA, ICH, EU regulations. Prepare dossiers for new product approvals, including artwork design and labeling requirements. Coordinate with cross-functional teams for formulation development, export documentation (DGFT), and licensing processes. Ensure legal metrology compliance by managing product registrations and maintaining accurate records. Provide guidance on regulatory matters to internal stakeholders and external partners. Handle regulatory documentation and submissions for Nutraceutical and Cosmetic products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Ect.) and international regulations. Ensure products comply with all legal and regulatory requirements of India and specific export markets. Regulatory handling and submission experience for Canada, USA, and European Union (EU) is mandatory. Review product labels, artworks, and marketing materials to ensure regulatory compliance. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents. Maintain up-to-date knowledge of changing regulations in export markets. Desired Candidate Profile 2-10 years of experience in pharmaceutical industry with expertise in drug regulatory affairs. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma). Strong understanding of FSSAI guidelines and regulations governing food supplements/nutraceuticals.

Role & Responsibilities Assist in API/intermediate manufacturing as per SOPs. Monitor production processes and ensure GMP & quality compliance. Maintain batch records, logbooks, and related documentation. Handle raw materials, samples, and finished goods safely. Operate equipment such as reactors, centrifuges, dryers, and filters under supervision. Collaborate with QA, QC, and Engineering teams. Maintain workplace hygiene and follow EHS guidelines Preferred Candidate Profile B.Sc. / M.Sc. in Chemistry or related discipline. 04 years of experience in API or intermediate manufacturing (Freshers can apply). Willing to work in rotational shifts. Good knowledge of GMP, safety protocols, and documentation practices. Strong attention to detail, willingness to learn, and teamwork attitude.

Corporate Quality Assurance is responsible for overseeing quality assurance programs across multiple shrimp processing facilities and ensuring compliance with food safety regulations, international standards, and company policies.

Role & responsibilities Development and Implementation of new product Develop fried snack prototype Crunchier than existing profile, oil-efficient with optimal moisture content Understands the ingredient interactions and multiple frying techniques and methods to create simulation for different bill of material Improve product shelf life without impacting any existing product specifications. Flavour Formulation & Seasoning Optimization: Flavors consistency, adhesion, effectiveness post application and stability across shelf life Exploring different cutting, drying, and frying parameters for consistency Organize sensory panels to refine crispiness and flavour perception. Quality Management & Assurance Develop, implement, and maintain the companys Quality Management System (QMS) to ensure product quality meets the highest standards. Lead the design, execution, and monitoring of the companys quality control policies and procedures, including raw material inspection, in-process checks, and finished product testing. Ensure adherence to food safety standards and regulatory requirements (e.g., FDA, HACCP, GMP, local food safety regulations). Manage the risk of quality failures, food recalls, or production downtime related to quality issues, ensuring swift action is taken to address any challenges To work towards reducing the defects in process and customer complaints by taking proactive actions. Compliance, Documentation, Risk Management Maintain accurate records of quality testing, inspections, and audits, ensuring proper documentation for traceability and accountability. Liaise with external auditors and regulatory bodies, preparing the organization for inspections, audits, and certifications as required. Monitor and evaluate supplier performance, conduct supplier audits, work closely with suppliers for quality assurance Lead, mentor, and develop a team of quality assurance (QA) and quality control (QC) professionals, including training on best practices, industry standards, and regulatory requirements. Preferred candidate profile Masters degree in Food Science or Food Technology At least 10-12 years of experience in quality assurance or quality control within frying industry, with at least 5-7 years in a leadership role. Core Technical Expertise Frying, moisture and oil control, textural science in fried products, deep understanding of starch behaviour Flavour & Seasoning Formulation Strong background in flavour development, taste optimization and Flavors retention In-depth knowledge of food safety regulations (e.g., FDA, HACCP, GMP), quality systems, and relevant certifications Strong attention to detail and analytical skills Agile, proactive and results-driven with a focus on continuous improvement. High level of integrity and commitment to maintaining food safety standards. Ready to travel across manufacturing locations

Location : Gurgaon Designation : Senior Engineer: Requirement Management/JAMA Administrator Requirements : The Engineer will assist in the ongoing adaptation and deployment of new tools such as JAMA. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes and procedures, in relation to these software tools, for the quality system. We would love to have you on the team if you are a self-starter with a strong project organization skill set, have a firm grasp of the design control process common in regulated industries, and are motivated to work in a highly technical, fast-paced, and cross-functional environment. What you will do: Work independently with members of the business to define and document the scope of new development requirements in an Agile environment. A demonstrated ability to understand and articulate complex requirements Ability to critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs Ability to assess the impact of new requirements on all upstream and downstream applications, systems and processes Work with our management team to establish suitable processes to support administrative, development, and change management activities Document standards, guidelines, templates, and best practice procedures for both administrators and users of the system. Administrative owner of the tools such as Jama software requirements management tool Perform and own tasks including, but not limited to: User account maintenance Create filters and custom reports or dashboards for each project, as needed. Customize workflows for multiple projects and maintain configuration of the tools. Manage release cycles and validate the software tools. Upgrade, backup, and baseline the project folders within each software tool. Work closely with Quality engineering team for compliance. Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upwards Creative and analytical thinker with strong problem-solving skills Must demonstrate exceptional verbal and written communication skills Must demonstrate ability to communicate effectively at all levels of the organization Previous experience working in a SCRUM or Agile environment preferred Previous software development experience is preferred Minimum Qualifications (Required): Bachelors degree in computer science, Computer Engineering or related field is preferred and minimum of 2+ years of experience as a Software/Quality Engineer in a regulated industry. Preferred Qualifications (Strongly desired): Knowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITY Understanding of engineering lifecycle phases and design control processes is preferred. Proven ability to design and implement new processes and facilitate user adoption. Knowledge of Requirement Management and Test Management, Traceability. Experience validating third party tools to comply with Quality Management system and to follow FDA guidance is preferred. Experience with software and hardware defect tracking processes is preferred. Ability to communicate and work with external software vendors is preferred. Ability to work independently and manage priorities on multiple tasks is required. Excellent verbal and written communication skills is required. Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is preferred Interested candidates please reach on - HR Sonali - 8879984232 OR Share updated profile on sonali.patne@enlinkit.com

Job Description Business Development Job Title: Manager / Sr. Manager/ AGM- Business Development Experience: 7– 15 Years Function: To handle Overall Business Development (Emerging & Semi Regulated Market) Job Responsibilities 1. Market Research and Strategy Development: Conduct research to identify new business opportunities and trends in regulated and emerging markets. Develop and implement strategic plans for market entry and expansion in existing or new market. Analyze competitor activities, market trends, and regulatory landscapes to adapt business strategies. 2. Business Development: Identify and build relationships with potential business partners, distributors, and clients in assigned markets. Negotiate and finalize agreements, ensuring mutual benefits and compliance with company policies. Maintain strong relationships with existing partners to ensure continued growth and collaboration. 3. Regulatory Compliance: Ensure business activities align with pharmaceutical regulations (FDA, EMA, local market rules). Collaborate with regulatory teams to navigate market entry requirements. 4. Client Relationship Management : Build and maintain strong relationships with key clients, partners, and stakeholders in international markets. Collaborate with clients to understand their needs and provide tailored solutions. 5. Team Leadership and Management : Supervise and manage a team of Business Development Managers, ensuring alignment with organizational goals. Provide mentorship, training, and support to team members to enhance their performance and skill sets. 6. Business Performance Tracking and Communication: Monitor sales performance, market share, and ROI in the assigned markets. Prepare periodic reports to provide insights and recommendations to senior management. Facilitate effective communication between the team and other departments. 7. Operational Oversight : Ensure smooth execution of business development activities and adherence to timelines. Oversee contract negotiations, proposal submissions, and closing deals. Interested candidates are can apply on Darpana: 9978604075 or can email me on darpana@upman.in

Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

About The Role : Job TitleRegulatory Advisory Analyst Corporate TitleNCT LocationMumbai, India Role Description The CRM & PBCRO Regulatory Adherence at Deutsche Bank ensures a CRM-wide discipline for the assessment and analysis of consultations and new rules and regulations and is playing a key role in leading, supporting and validating regulatory driven changes initiatives impacting our credit systems and processes. Your role will primarily be focussed on global regulations impacting all international credit portfolios in Corporates & Investment Bank (CIB) as well as domestically in Germany (PB Germany) and in the International Private bank (IPB). Members of the team are located in Frankfurt, Bonn und Mumbai. This position is within Regulatory Adherence in Mumbai servicing global locations. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities You are responsible for Regulatory Adherence activities along the regulatory life-cycle related to Credit Risk including tracking and review of incoming new rules & regulations and consultations affecting Credit Risk. You will support the performance of global impact assessments and tracking of potential gaps resulting in remediation- and corresponding project/ change activities, dependent on materiality of the regulations in conjunction with a Senior Analyst. You identify and analyse regulatory trends and supervisors priority topics and prepare bankwide advocacy work including project support in key regulatory initiatives (i.e. CRR; MaRisk) with corresponding change initiatives. You will support coordination and Senior Regulatory Leads in regulatory driven changes initiatives impacting our (IT) systems and processes as part of the adherence analysis and advocacy work, i.e. joining project teams and working groups to drive quality standards and control frameworks to meet new regulatory requirements. You will actively coordinate stakeholders feedback of the areas impacted including coordination of Subject Matter Experts in different credit areas. You are responsible for reporting tracking items, and preparation of Management presentations. Your skills and experience A Masters degree or the equivalent experience or qualifications Min 3yrs Background in a Risk function within the financial services industry. Credit risk management knowledge including experience in credit process and/or methodologies and/ or credit portfolio management appreciated Regulatory knowledge with focus on credit risk relevant or related regulations. Experience in project and change management with good analytical and conceptual skills with the ability to solve complex problems, develop innovative and structured solutions and ability to see the broader picture front-to-back and assess dependencies and interdependencies Very good communication and social skills with excellent client and service focus, as well as confidence in working with decision-makers from all levels of the organisation being a good team player Fluent in Microsoft Office tools Fluent in English How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.

IT Security - Team Lead - Bengaluru - Work from office Proven experience (5+ years) in IT security with team lead role experience. Deep knowledge of Security Technologies (like., Active Directory, Endpoint Protection, Web Gateway, DLP, firewalls, SIEM, IDS/IPS, Encryption, PAM, WAF, Vulnerability Assessment and Patch Management). Experience with Vulnerability Scanning Tools and Risk Assessment methodologies. Lead and mentor a team of Cyber Security Professionals, ensuring a high level of motivation, performance and continuous professional development. Manage Team workload, prioritize tasks and allocate resources effectively to meet security goals. Oversee day-to-day security operations, including security monitoring, incident detection and incident response. Analyse security logs and data to identify threats, vulnerabilities and anomalies and escalate issues as needed. Collaborate with IT and Development teams to integrate Security Best Practices into system architecture, network design and application development. Continuously evaluate and improve the company's security policies, procedures and controls. Foster a collaborative environment, providing support and guidance to junior and mid-level team members. Provide regular reports to Senior Management and Stakeholders on the Security Reports & Posture of the organization. Maintain clear and effective communication during security incidents and with other departments, ensuring timely resolution of issues. Conduct Security Awareness training for employees to promote security best practices. Ensure compliance with relevant industry regulations (e.g., GDPR, HIPAA, NIST, FDA). Stay current with the latest trends, tools and technologies in cyber security and bring innovation to the security program. Coordination with Vendor for Improvements and Deployment of new technology. ********************************************************************************* If interested with this opportunity, Kindly - do share your updated Resume along with below required details to devaraj.v@valuepointsystems.com OR WhatsApp to 8867682884 Notice Period: Total Experience: Relevant Experience: Current Location: Preferred Location: Current CTC: Expected CTC:

Role & responsibilities Regulatory Affairs Associate I Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established “CLIENT”procedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements – Education and Experience Relevant qualification and/or experience in science Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of “CLIENT”business and processes Some knowledge of “CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Reporting Relationship Direct Reports – None Indirect Reports – None Interested candidate may reach @ 9845914559 or drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

Skills & Keywords: Regulatory Affairs | RA Compliance | Medical Devices | Pharma Regulatory | FDA | CE Marking | ISO 13485 | Clinical Research | Quality Assurance | Risk Management

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Job Title Software Technologist Job Description Analyses, designs, tests, codes, secures, debugs, modifies, deploys, integrates and maintains (system) software enhancements, test environment and/or new software. Uses state-of-the-art technologies and practices. Interacts with users / product owners to define / adjust requirements and/or necessary modifications. Keeps abreast of technical developments and practices in own field through literature, courses/trainings, technical contacts, and competitive environment. Applies agile software development methods as a member of agile teams. To succeed in this role, you should have the following skills and experience. BE/BTech/MCA/MTech with 4-9 Years of exp in Embedded Systems As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct others and architect solutions. Software design and development in embedded applications using C/C++ is required; C# and Python is preferred. Experience in RTOS. Experience in ARM architecture, ARM microcontrollers. Working knowledge in usb, ethernet, I2C,SPI, UART, Timers, etc. Experience in software development in medical industry or highly regulated industry. Experience with IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards is highly preferred Experience in Agile SW Development practices. Experience in scaled agile framework (SAFe) is preferred Demonstrated experience working with real time operating systems. ThreadX is required, FreeRTOS is preferred Knowledge and application of the following standards and interfaces is preferred As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct others and architect solutions. Skill expectations: Software design and development in embedded applications using C/C++ is required. Experience in RTOS. Experience in ARM architecture, ARM microcontrollers. Working knowledge in usb, ethernet, I2C, SPI, UART, Timers, etc. Experience in software development in medical industry or highly regulated industry. Experience with IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards is highly preferred Experience in Agile SW Development practices. Experience in scaled agile framework (SAFe) is preferred Demonstrated experience working with real time operating systems.

Group Purpose Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization. Job Summary Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence. Key Activities Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback Effectively communicates regulatory requirements to Regulatory Affairs staff Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Works with limited supervision according to predefined regulatory intelligence workplans Applies tools and systems to deliver agreed intelligence objectives Communicates progress and escalates issues impacting delivery of intelligence outputs Provides suggestions for improvement of processes, systems and tools employed within the function. Knowledge and Skills Basic: Regulatory intelligence monitoring, analyzing, and interpreting global regulatory developments to ensure compliance and inform strategic decision-making. Knowledge of regulatory agency guidelines and procedures (major and non-major markets) Knowledge of regulatory intelligence systems and platforms Understanding and application of aspects of global and local regulatory process Project management skills Presentation and interpersonal communication skills Preferred: Global Regulatory Intelligence monitoring experience Education and 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 and 10 years of directly related experience Education and Experience (preferred) A bachelor's degree in life sciences or a related field; advanced degrees may be preferred. A minimum of 5 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role within the pharmaceutical, biotechnology, or medical device industries. In-depth knowledge of global regulatory frameworks and guidelines, such as those from the FDA, EMA, and other health authorities. Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights. Excellent communication skills, both written and verbal, to effectively present information to diverse audiences. Proficiency with regulatory intelligence databases and software tools.

- 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.