71 Regulatory Documentation Jobs

As the Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be responsible for ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will coordinate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have a minimum of 5 years of experience in compliance, preferably in crypto, fintech, or banking sectors. You must possess a strong understanding of FIU regulations, AML/CFT laws, and FATF guidelines. Experience working in or with FIU-regulated entities is highly preferred. An excellent knowledge of crypto asset risks, wallet monitoring, and KYC/KYB norms is essential. An LLM or Masters in Law/Financial Compliance would be advantageous. Joining ParaaCrypto will give you the opportunity to be at the regulatory forefront of India's crypto ecosystem. You will have a high-impact role with leadership responsibilities and will be offered a competitive package with remote flexibility. If you are ready to take on this challenging and rewarding role, please apply now by sending your application to admin@paraacrypto.com.,

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. The company has been consistently ranked amongst the top five pharmaceutical companies in India, with a portfolio that includes renowned brands like Clavam, Pan, Pan-D, and Taxim-O, which are among the top 50 pharmaceutical brands in the country. As a Medical Advisor at Alkem Laboratories Limited, your primary role will be to actively contribute to the organization by ensuring the scientific, technical, and ethical soundness of all policies, statements, and endeavors. You will be responsible for supporting the division medically in all activities related to the portfolio and providing high-quality and timely service to internal and external stakeholders. Your key responsibilities will include supporting the development and promotion of the allocated portfolio under the supervision of the Line manager or mentor. This will involve providing strategic inputs for marketing/brand plans, medical development plans, and the design and execution of medical-marketing programs/clinical programs to enhance access to medicines. You will be involved in creating and reviewing promotional, training, and Continuing Medical Education (CME) material in compliance with industry codes and medical correctness. Additionally, you will participate in customized promotional/educational interactions with Key Opinion Leaders (KOLs) under the guidance of the Line manager or mentor. This may include customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, medical projects, and studies. You will also collaborate with stakeholders to plan research projects, develop protocols, and provide accurate medical information to internal and external customers in adherence to relevant SOPs/policies. Furthermore, you will be responsible for imparting medical training to new sales staff on basic sciences, therapeutic areas, and assigned products. You will conduct refresher training for sales staff through ongoing initiatives and provide pre-launch and launch training for new products. Your role will also involve supporting New Product Evaluation (NPE), Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products. To qualify for this position, you must hold an MBBS & MD Pharmacology degree. The ideal candidate will have 1 to 4 years of experience in medico marketing, demonstrating a strong foundation in medical knowledge and marketing principles. Join Alkem Laboratories Limited to make a meaningful contribution to the advancement of healthcare through innovative pharmaceutical solutions.,

We are looking for a dynamic Chartered Accountant (Fresher) to join our Compliance and Taxation Team . This is a hands-on role focused on direct and indirect tax compliance , tax audits , and regulatory filings across India and international jurisdictions . If youre looking to build deep expertise in tax & finance at one of India’s leading fintech SaaS companies, this is the opportunity for you. Key Responsibilities: Prepare and file GST, VAT, TDS/TCS, Equalization Levy returns Assist in income tax computations , advance tax , and tax audit reports Support Transfer Pricing documentation, policies, and forms Handle tax assessments, appeals , and appear before tax authorities as required Reconcile tax GLs and support in tax-related accounting Work closely with internal finance, legal, and external consultants Assist in multi-jurisdictional tax compliance (APAC, Europe) Required Skills: Strong understanding of Direct & Indirect Taxes Knowledge of tax audits , return filings , and transfer pricing Proficiency in MS Excel ; familiarity with SAP is a plus Excellent communication & presentation skills Ability to work independently and in cross-functional teams Educational Qualification: Chartered Accountant (CA Fresher) Articleship experience in Taxation/Compliance preferred Why Join Us: Exposure to domestic and global tax environments Opportunity to work with India’s leading fintech SaaS platform Collaborative and high-growth work culture Room to grow into strategic roles within the finance function

Dossier Preparation & Compilation: Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations. Regulatory Strategy & Market Compliance: Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions. Bioequivalence Studies & Compliance: Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions. Product Lifecycle Management: Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance. Product Registration & Market Expansion: Handle product registration processes, liaise with authorities, and ensure smooth approvals in targeted regions. Technical File Review: Review technical documentation to ensure accuracy and completeness for regulatory filings. Regulatory Compliance & Audits: Ensure compliance with country-specific guidelines including WHO-GMP, ICH, and other global standards. Regulatory Documentation & Reporting: Maintain accurate and updated regulatory records and provide timely reports to senior leadership. Stakeholder Management: Act as the key liaison between regulatory bodies, internal departments, and external partners. Process Improvement & Team Leadership: Mentor junior team memb

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requires collaboration with cross-functional teams to ensure timely and accurate preparation of regulatory documents , risk files, and performance data packages for international regulatory approvals. Familiarity with immunoassays, including ELISA and fluorescence-based methods, particularly for infectious disease diagnostics, is preferred. Key Responsibilities: 1. Performance Evaluation Documentation: Author and maintain IVDR-mandated performance evaluation documents, including: Scientific Validity Reports (SVRs) Analytical Performance Reports (APRs) Clinical Performance Reports (CPRs) Performance Evaluation Reports (PERs) Ensure alignment with EU IVDR Annex XIII, MDCG guidelines, and ISO standards. Compile and interpret data from internal validations, clinical studies, and external literature. Coordinate with laboratory/R&D teams to ensure appropriate data generation for APRs and CPRs. 2. Scientific Validity & Literature Review: Conduct systematic literature searches using PubMed, Embase, Scopus, and other databases. Define and document search strategies, selection criteria, and appraisal methodology. Evaluate and synthesize scientific evidence supporting biomarkercondition associations. Develop literature matrices, evidence tables, and justification summaries for SVRs. 3. Regulatory Documentation & Global Registration Support: Prepare and maintain CE Technical Files/Design Dossiers and ensure alignment with GSPRs. Support global product registration activities by preparing and submitting regulatory documentation as per country-specific requirements. Ensure timely preparation and submission of documents for new market approvals and renewals. Assist in regulatory gap assessments and remediation planning for international markets. Contribute to Risk Management Files (ISO 14971) and Post-Market Performance Follow-up (PMPF) documentation. 4. Cross-Functional Coordination & Audit Support: Collaborate with RA, QA, R&D, PMS, and manufacturing teams for data collection and alignment. Participate in internal audits and assist with responses to Notified Body and regulatory authority observations. Support vigilance reporting and post-market analysis through literature and performance data review. Required Skills & Experience: 5-7 years of experience in regulatory affairs and clinical/performance documentation for IVDs or medical devices. In-depth knowledge of EU IVDR, ISO 13485, ISO 20916, CLSI guidelines, and applicable international regulatory standards. Proven experience in preparing performance evaluation documents and conducting systematic literature reviews. Strong understanding of immunoassay technologies and infectious disease diagnostics. Excellent documentation, data analysis, and regulatory writing skills.

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be tasked with ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will collaborate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have a minimum of 5 years of experience in compliance, preferably in crypto, fintech, or banking sectors. A strong understanding of FIU regulations, AML/CFT laws, and FATF guidelines is essential. Experience working in or with FIU-regulated entities and excellent knowledge of crypto asset risks, wallet monitoring, and KYC/KYB norms are also required. An LLM or Masters in Law/Financial Compliance would be advantageous. Joining ParaaCrypto will offer you the opportunity to be at the regulatory forefront of Indias crypto ecosystem. This role provides high-impact leadership responsibilities, a competitive package, and remote flexibility. If you are ready to take on this challenging and rewarding position, please apply by sending your resume to admin@paraacrypto.com.,

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will involve direct reporting to the FIU (Financial Intelligence Unit of India), enforcing internal policies, and monitoring risks proactively. You will act as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. It will be your responsibility to ensure compliance with Indias VDA regulations and global best practices. Additionally, you will be updating internal SOPs, maintaining regulatory documentation, and coordinating with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have at least 5 years of experience in compliance, preferably in crypto, fintech, or banking sectors. A strong understanding of FIU regulations, AML/CFT laws, and FATF guidelines is essential. Experience working in or with FIU-regulated entities is a plus. You should possess excellent knowledge of crypto asset risks, wallet monitoring, and KYC/KYB norms. An LLM or Masters in Law/Financial Compliance would be preferred. Joining ParaaCrypto will offer you the opportunity to be at the regulatory forefront of Indias crypto ecosystem. You will have a high-impact role with leadership responsibilities and a competitive package. Moreover, remote flexibility is provided to ensure a healthy work-life balance. If you are looking to make a difference in the compliance landscape of the crypto industry, apply now by sending your resume to admin@paraacrypto.com.,

Role & responsibilities We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier Compilation, Pharma Regulatory, RA Executive

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A key responsibility includes the preparation and maintenance of Risk Management Plans (RMPs), which involve identifying potential risks, outlining mitigation strategies, and ensuring regulatory compliance. Continuous monitoring of safety updates and detection of safety signals for client products is essential. All activities must be conducted in strict compliance with standard operating procedures (SOPs) and applicable regulatory requirements. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, and EVWEB Updates Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) Risk Management Plan (RMP) and Regulatory Documentation ICSR Processing and Reference Product Comparison

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), Regulatory Documentation, Reference Product Comparison, ICSR Process,

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be responsible for ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will collaborate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have at least 5 years of experience in compliance, preferably in crypto, fintech, or banking sectors. A strong understanding of FIU regulations, AML/CFT laws, and FATF guidelines is essential. Experience working with or in FIU-regulated entities and excellent knowledge of crypto asset risks, wallet monitoring, and KYC/KYB norms are also required. An LLM or Masters in Law/Financial Compliance would be preferred. Joining ParaaCrypto will provide you with the opportunity to be at the regulatory forefront of India's crypto ecosystem. This role offers high-impact responsibilities with leadership opportunities, a competitive package, and remote flexibility. If you are excited about taking on this challenging and rewarding position, apply now by sending your resume to admin@paraacrypto.com.,

Conduct NPD, process optimization, scale-up & value engineering. Develop synthetic routes, validate methods, identify raw material alternatives. Maintain documentation. Support validation & transfers. Coordinate with QA, QC & production.

Education Qualification - Pursuing or completed BSc or MSc in Microbiology, Life Sciences, or Biotechnology What We Want You To Do Execute required activities as part of ISO 13485 and ISO 15189 compliance Undertake activities as part of manufacturing documentation under ISO 13485 Undertake activities in molecular kit development and kit packaging departments Preparation of regulatory document dossier Requirements The candidate must have the ability to execute tasks and document information independently. Have a basic understanding of quality assurance and quality checks Awareness of ISO 13485 and ISO 15189 Skills Keen attention to details. Ability to critically evaluate scientific literature and integrate information from multiple sources. Proficiency in Google & Microsoft Office Suite and other relevant software applications. Ability to work independently with minimal supervision as well as collaboratively in a team environment. Excellent organizational and time management skills with the ability to prioritize tasks effectively Strong interpersonal and communication skills with the ability to interact professionally with diverse stakeholders Note: This is a paid internship.Skills: time management, regulatory documentation,documentation,iso,regulatory affairs,molecular kit development,genomics,quality assurance processes, google suite,interpersonal skills,iso 13485,microsoft office suite, proficiency in google & microsoft office suite,iso 15189,attention to details,quality assurance,biotechnology, communication,communication skills,scientific literature evaluation, organizational skills

Immediate requirement for Executive - Regulatory function for one of the leading pharma company Position : Executive ( Regulatory function ) Educational qualification: MSc/MPharm Experience : 3 to 6 years of relevant experience. CTC : up to 6 LPA Contract Period: 1 Year (It can be extended based on performance ) Work Location : Thane office (Maharashtra) Transport provided : Yes (from Thane station) Working Mode ( Remote / Hybrid ) : Work from office. Shift timings : 9 am to 5.30pm Main Responsibilities: KEY RESPONSIBILITIES 1) To maintain high degree of quality of documents required for submissions to get the approval without deficiency / non-critical deficiency. 2) Timely readiness and submission of documents / dossier for variation / new submissions and renewals in different countries. 3) To follow Global Working Instructions and local SOPs for new submissions, variations and renewals and also support DRA initiatives. 4) Proven expertise in scientific writing and regulatory documentation Strong project management capabilities and ability to work independently Familiarity with global regulatory requirements and submission processes Key Competencies: Ability to diligently communicate with both internal and external stakeholders. Strong ability to collaborate within the team and also with all other functions. Excellent written/spoken communication skills. Computer Literacy. Interested candidates share cv : busiraju.sindhu@manpower.co.in Whats App : 7013970562

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Regulatory Monitoring & Analysis: Continuously monitor, track, and analyze new and evolving policies, regulations, rules, tariff orders, grid codes, and standards issued by central (e.g., MoP, MNRE, CEA, CERC) and state-level authorities. Required Candidate profile • Permits, Licenses & Approvals Management (Project Lifecycle): Manage the end-to-end process of obtaining all required licenses, permits, and approvals for solar, wind, and hybrid power projects.

You will be joining a global investment bank in a full-time hybrid role as a Manager of Cross-border Regulatory Compliance. This role is based in Bangalore and involves overseeing cross-border compliance, ensuring adherence to international regulations, and managing compliance audits. Your daily responsibilities will include developing and implementing compliance policies, monitoring regulatory changes, and providing guidance on regulatory issues. Additionally, you will collaborate with international teams to ensure consistent compliance practices. Your key responsibilities will include leading the implementation and monitoring of the cross-border controls framework across global Asset Management entities, acting as the Subject Matter Expert for cross-border processes and tools, producing and managing global Management Information for governance forums, supporting training development and tracking for cross-border compliance, and serving as the first point of contact for business queries related to cross-border regulations. You will also collaborate with Legal, Compliance, IT, and Business teams to ensure accurate interpretation and application of regulations, provide user support, identify enhancement opportunities for cross-border tools, and ensure adherence to Risk, Compliance, Global Standards, and FCC requirements. To be successful in this role, you should hold a Bachelor's degree in Finance, Business, Law, or a related field, have 4-8 years of experience in the financial industry, preferably within Asset Management, possess 2-4 years of experience in risk and controls management with a focus on cross-border regulation or regulatory compliance, have experience working with Legal or Regulatory Compliance teams, demonstrate strong communication, analytical, and interpersonal skills, be able to manage multiple tasks in a fast-paced, global environment, and have proficiency in working with MI tools and regulatory documentation.,

Optra Scan Pvt Ltd is a renowned provider of digital pathology solutions, transforming the landscape of pathology practices worldwide by streamlining the management and interpretation of diagnostic information. With our innovative technology, we empower pathologists to enhance efficiency, precision, and patient care through the integration of digitalization and artificial intelligence. As a Technical Writer - Regulatory at OptraSCAN, you will play a pivotal role in creating, organizing, and updating regulatory documentation essential for product approvals, certifications, and market entry across global jurisdictions. This position demands a blend of strategic regulatory planning and meticulous technical writing focused on ensuring adherence to international standards like ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations. Your responsibilities will include preparing and managing various regulatory documents such as Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files, Declarations of Conformity, and FDA submissions. Collaboration with cross-functional teams comprising R&D, QA, Clinical, and Marketing departments will be essential to gather inputs for the compilation of submission materials. In the realm of technical writing, you will be tasked with crafting, reviewing, and refining Standard Operating Procedures (SOPs), work instructions, user manuals, labeling, and Instructions for Use (IFUs) to ensure accuracy, clarity, and regulatory compliance. Your ability to translate intricate technical information into easily comprehensible documentation will be critical in this role. Staying abreast of regulatory updates such as EU MDR and FDA guidelines will be imperative to ensure that internal processes and documentation align with the latest standards. Compliance with key regulations like ISO 13485, ISO 14971, IEC 62304, IEC 60601, EU MDR 2017/745, and FDA 21 CFR Part 820 will be a focal point of your responsibilities. Moreover, you will provide support for internal audits and inspections by maintaining meticulous and readily accessible documentation. Assistance in Corrective and Preventive Actions (CAPA) documentation and post-market surveillance reporting will also be expected as part of your Quality System Support duties. To qualify for this role, you should hold a Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field, accompanied by at least 3-6 years of experience in regulatory writing or regulatory affairs within the medical device or healthcare product domain. Proficiency in global medical device regulatory frameworks, exceptional written English and technical writing skills, as well as strong organizational and project management capabilities are essential prerequisites. Preferred qualifications for this position include prior experience in preparing 510(k) submissions, CE Mark applications, or similar regulatory filings. Knowledge of digital pathology, imaging devices, or software as a medical device (SaMD) would be advantageous, along with a certification in Regulatory Affairs such as RAPS RAC. Join Optra Scan Pvt Ltd in revolutionizing the digital pathology landscape and leveraging your regulatory expertise to drive impactful advancements in healthcare technology.,

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

As a Medical Gas Plant Operator specializing in Engineering & Maintenance, you will be responsible for ensuring the safe and efficient operation of medical gas production equipment and related systems within healthcare facilities. Your primary focus will be on maintaining equipment functionality, overseeing preventive maintenance schedules, troubleshooting operational issues, and ensuring compliance with regulatory standards governing medical gas systems. Key Responsibilities: Equipment Operation : Operate and monitor medical gas production equipment, including compressors, cylinders, storage tanks, and distribution systems, to ensure continuous and reliable gas supply. Preventive Maintenance : Develop and implement preventive maintenance schedules for medical gas production equipment and associated components to minimize downtime and ensure optimal performance. Troubleshooting : Identify and diagnose equipment malfunctions or operational issues, and perform corrective actions to restore functionality promptly. Repairs and Servicing : Conduct repairs, replacements, and servicing of medical gas equipment and systems as needed, adhering to manufacturer guidelines and safety protocols. Quality Control : Monitor gas purity levels and conduct regular testing to ensure compliance with industry standards and regulatory requirements, such as NFPA (National Fire Protection Association) guidelines and FDA (Food and Drug Administration) regulations. Documentation and Record-Keeping : Maintain accurate records of maintenance activities, equipment inspections, repairs, and gas quality tests to ensure compliance with regulatory documentation requirements. Safety Compliance : Adhere to all safety protocols and guidelines governing the operation of medical gas systems, including proper handling of gases, equipment shutdown procedures, and emergency response protocols. Training and Compliance : Provide training to staff members on safe handling practices, equipment operation procedures, and regulatory compliance requirements related to medical gas systems. Emergency Response : Respond promptly to emergencies or equipment failures, following established protocols to mitigate risks and ensure the safety of patients and healthcare staff. Collaboration : Coordinate with other departments, such as Facilities Management, Biomedical Engineering, and Environmental Health and Safety, to ensure seamless integration of medical gas systems with facility infrastructure and operations.

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing facilities in India, Oman, and New Zealand. Listed on the Bombay and National Stock Exchanges, Zydus Wellness is led by Chairman Dr. Sharvil Patel and CEO Tarun Arora, serving customers in over 25 countries across three continents. S. No Get to know our organization – Click on the below links 1 Company Website 2 Zydus Corporate Park Job Title: Assistant Manager - Food Regulatory Affairs Location: Ahmedabad- ZCP, Gujarat, India Department: Regulatory Affairs Functional Reporting: Manager Regulatory Affairs Administrative Reporting: Manager Regulatory Affairs Job Type: Full-time Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organization’s products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations. The incumbent will play a key role in safeguarding the company’s regulatory standing and facilitating market access for new and existing products Key Responsibilities: Regulatory Compliance Management: Ensure compliance with food safety laws, regulations, and standards (e.g., FSSAI regulations, BIS standards, etc.) in India. Monitor regulatory changes and assess their impact on company operations. Liaise with internal teams (R&D, Quality Assurance, Marketing, Legal) to ensure that new products meet regulatory requirements. FSSAI & Legal Documentation: Assist in obtaining and renewing relevant licenses, registrations, and certifications from regulatory authorities such as FSSAI, LM, and other local bodies. Prepare, review, and maintain regulatory documentation and product dossiers for submission to relevant authorities. Work on product labeling, claims, and packaging to ensure compliance with the Food Safety and Standards Act. Risk Assessment and Management: Evaluate potential risks related to food safety, labeling, and regulatory compliance, and propose corrective measures. Conduct risk analysis on new and existing food products to mitigate any potential non-compliance. 4. Financial Support the cost-effective management of regulatory submissions and compliance-related activities 5. Customer Ensure timely and accurate submissions to regulatory authorities to meet business timelines. Address regulatory queries and facilitate smooth approval processes for product registrations 6. Process Prepare, review, and submit regulatory documents, product dossiers, and compliance reports. Maintain regulatory records, databases, and ensure up-to-date documentation. Monitor and interpret changes in food safety regulations and communicate impact to internal stakeholders. Coordinate with R&D, Quality, and Production teams to ensure compliance of product formulations and labeling with regulatory requirements 7. People Collaborate with cross-functional teams to align regulatory activities with business objectives Develop strong working relationships with external regulatory bodies and industry association Key Deliverables Timely submission and approval of regulatory filings for new and existing products. Maintenance of accurate regulatory documentation and compliance databases. Proactive identification and communication of regulatory changes impacting business operations. Key Requirements: Educational Qualification Master’s degree in Dairy Technology or Dairy Sciences (Preference NDRI- Karnal) Additional certification or training in regulatory affairs is a plus. Experience: 1-3 years of experience in regulatory affairs, specifically related to food(Dairy) regulatory and compliance in India. Experience in preparing and handling regulatory submissions, licenses, and compliance documentation Knowledge of food safety regulations and industry standards in India. Skills and Competencies: In-depth knowledge of FSSAI regulations, food safety laws, and compliance requirements in India. Knowledge of national and international food regulations and standards (e.g., FSSAI, Codex) Expertise in regulatory documentation, labeling compliance, and product registrations Familiarity with food safety systems and quality management practices Strong written and verbal communication skills. Attention to detail with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills. Ability to work cross-functionally with internal teams and regulatory authorities. Personal Attributes: Proactive and self-driven with the ability to work independently. Strong organizational skills with the ability to prioritize tasks effectively. Ability to maintain confidentiality and handle sensitive information with discretion. Behavioral Competencies Zydus Neev Behavioural Competency Framework Clear and concise communication skills to convey complex regulatory requirements Strong interpersonal skills to work with cross-functional teams and external authorities Meticulous approach to maintaining regulatory documentation and ensuring compliance

As the Head of Production, you will play a crucial role in the planning, coordination, and control of manufacturing processes, focusing on Factory Layout and Production Layout. Your responsibilities will include collaborating with internal and external stakeholders to provide technical support, ensuring the production of top-notch products and adherence to best business practices. You will lead and manage teams and projects across the organization, offering clear direction, inspiration, and guidance to drive excellence and motivate staff towards success. Your primary responsibilities will involve designing and validating factory layout and production layout, developing engineering bills of process and resources, and planning manufacturing processes for assembly. You will be tasked with conducting capacity and cycle time calculations, as well as planning and designing equipment, tooling, jigs, and fixtures. Additionally, you will be involved in supplier qualification processes, developing quality metrics, and performing various analyses to ensure optimal performance and efficiency. Furthermore, you will be responsible for planning and executing MES architecture in line with ISA95 standards and implementing Industry 4.0 strategies. Managing factory operations, ensuring compliance with regulatory requirements, conducting safety and risk analyses, and implementing ISO standards will also be part of your role. To excel in this position, you should hold a BE/ME degree in Mechanical, Automobile, or Industrial Engineering, with a strong background in Factory and Layout planning. Experience in automated and manual assembly lines, tool design, manufacturing processes, and knowledge of quality standards are essential. Familiarity with GD&T, tolerance stack-up analysis, APQP, DFMEA, PFMEA, as well as PLM, ERP, and ISO standards is required. Knowledge of CMM, Blue light scanning, and I4.0 principles will be advantageous. Key competencies for success in this role include being results-oriented, self-motivated, and possessing a problem-solving attitude. Integrity, teamwork, and a sense of ownership are critical traits for this position, as is a commitment to driving performance and contributing to the organization's success.,

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Identifying opportunity to increase presence by developing plan to make potential partnerships, enhance distribution and stepping into new markets and methods to enhance efficiency within the internal sales and support team. Identifying the business trend, plan and participate in key tenders to draw maximum business opportunity. Effectively design and assign target to the downline, taking periodic review for mid-way correction, provide clear direction to plan achieving the target and meet business objective. Accountable for maintaining a healthy P&L by over-viewing and devising effective strategy around setting correct pricing to quote, mobilizing of old stock, timely order placement to mitigate the risk of expiry of RM/PM, timely payment collection as per agreed terms. Overview and manage effective coordination with all internal stakeholders like PPIC, Logistics, RA, Finance and ensure best customer service experience is extended to overseas customers. Ensure the team adheres to company SOP by conducting periodic review/ audit and taking corrective measures for any deviation, guide the concern and being an enabler to maintain a healthy work culture and providing overall service excellence to customers. Customer Relationship Management Overview and ensure customer queries are handled properly. Overview clients feedback on any specific aspect, ensure devising a proper resolution to provide optimized customer experience and retention. Directly getting involved wherever needed to earn better customer loyalty and service assurance. Analysis & Reporting Maintaining database of prospects & provide weekly/monthly progress report to the leadership team for taking key decisions. Track and analyze data around competitors activities, IPMS/ Export/ Market Intelligence Reports, new opportunities, best practices and other changes in the industry to discuss and effectively develop business development/ expansion strategy. CANDIDATE PROFILE: Well versed with latest market trends in order to generate leads & building connections. Prefer MBA in International Business for this role. Having a strategic bent of mind with strong analytical ability. Having sound communication, leadership and interpersonal relationship skill. Having strong market contact in global market. Must be aware of current regulatory affairs related regulations.