3208 Regulatory Affairs Jobs - Page 33

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

Role & responsibilities Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support for complex formulations , including injectables and liquid dosage forms Collaborate with R&D, QA, QC, ...

Role & responsibilities Skills Required: Ensuring contract compliance, mitigating legal risks, and resolving disputes to protect the company's interests Key Responsibilities Administer the Contract Life Cycle Management which includes pre award and Post award Contract Management. Understand and analyze the complete scope of work, in terms of technically and contractually. Review of regular correspondence with Client with respect to all the contractual and on any other site related issues. Ensuring compliance with all contractual & statutory requirements of the project till closure. Formulating claims for variations, price escalation, extension of time, compensation for extended stay, etc. Re...

Site Name: Warsaw, Bengaluru Luxor North Tower, Cairo Boomerang, Poznan Grunwaldzka Posted Date: Oct 1 2025 Are you looking for an opportunity to work on global projects and make a meaningful impact in the pharmaceutical industry Join the Delivery Team within SMMP as a Senior Regulatory Specialist and play a pivotal role in driving global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products. As a Senior Regulatory Specialist, you will take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Pharma business. Your responsibilities will inc...

We are seeking a highly accomplished and strategic Company Secretary to join our leadership team. The role demands a seasoned professional with deep expertise in corporate governance, statutory compliance, regulatory affairs, and strategic advisory to the Board of Directors. The ideal candidate will come with strong experience in large manufacturing organizations with diverse business lines, driving excellence in governance and contributing to business growth. Key Responsibilities Act as the principal advisor to the Board of Directors on corporate governance and compliance matters. Ensure timely and accurate compliance with Companies Act, SEBI Regulations, FEMA, and all other applicable corp...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

We are seeking a highly experienced and driven Global Process Owner to lead the transformation of our Order to Cash (O2C) processes within our finance and accounting function. The successful candidate will be responsible for driving the analysis, design, and implementation of process improvements across multiple business divisions and regions, including the Americas, EMEA, and APAC. This role requires a strong leader who can influence, and impact work delivered from multiple centers across US and Chennai, India, and collaborate with multiple senior stakeholders at the client end. Lead the transformation of the O2C process, focusing on optimizing efficiency, reducing costs, and enhancing cust...

Niraj Public School is looking for Art & Craft Teacher to join our dynamic team and embark on a rewarding career journey Teach art and craft techniques and concepts to primary school students. Develop creative and age-appropriate lesson plans and projects. Demonstrate various art mediums and methods. Encourage creativity and self-expression through artistic activities. Showcase students' artwork through exhibitions and displays. Collaborate with other teachers on interdisciplinary projects. Evaluate and provide feedback on students' artistic progress. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our use...

Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Roles and Responsibility Manage and process payments transactions efficiently. Collaborate with cross-functional teams to resolve payment-related issues. Develop and implement new payment systems and processes. Analyze payment trends and provide insights for improvement. Ensure compliance with regulatory requirements and industry standards. Provide excellent customer service and support to clients. Job Requirements Strong knowledge of payment processing and reconciliation. Experience with payment gateways and payment system...

About The Role Project Role : Application Support Engineer Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems. Must have skills : Asset Management Good to have skills : Asset Life Cycle ManagementMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Support Engineer, you will act as software detectives, providing a dynamic service identifying and solving issues within multiple components of critical business systems. Your day will involve troubleshooting, analyzing, and resolving software-related issues ...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: BCom Years of Experience: 1 to 3 years Language - Ability: English(Domestic) - Intermediate What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medic...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Successful candidates must be eager to dive deep into processes and have a proven record of delivering meaningful risks and recommendations to the business. The candidate should have outstanding auditing skills, problem solving skills, systems and process knowledge, and a passion for customer service. Specific core responsibilities are below: Perform risk assessment of the services and functions in FinOps Perform end to end audits, including scoping, fieldwork, and reporting. Evaluate design and effectiveness of FinOps controls Evaluate policy and process exceptions Provide trainings that improve and raise the bar on controllership with respect to policies and other requirements Support exte...

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

Leads the management of Government Affairs, Public policy, liaison with State & local level Governmental & Non-Governmental agencies and Relationship management. Liaison and maintain public relations. Role & responsibilities Establish and maintain effective working relationships with key clients, local and central government officials, and media representatives To observe and report on social, economic, and political trends that might affect the company Liaison with various State & Central Departments for permits, clearance & approvals for land acquisition, licenses, etc Coordinate with various departments/agencies for statutory clearances Act as a point of contact for various external agenc...

Roles and Responsibilities Lead and manage CAPA process from initiation to closure. Coordinate root cause investigations and ensure robust corrective actions. Track and report CAPA metrics and trends to management. Drive quality improvement projects and cross-functional collaboration. Ensure timely documentation and regulatory compliance. Facilitate audits and provide CAPA-related evidence. Support risk management and preventive action initiatives. Qualifications Bachelor’s degree in Engineering, Mechanical or related field. 7+ years’ experience in Quality/Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project ma...

Regulatory & Licensing Prepare and manage applications for WHO certification, manufacturing & wholesale licenses, renewals, FOSCOS, FDA, and other statutory approvals. Handle CBN export NOCs, biodiversity returns, and related compliance filings. Coordinate with FDA officials (domestic & overseas) during licensing, audits, and certifications. Maintain compliance with cGMP, pharmacopoeial & non-pharmacopoeial standards, and GS1 barcode implementation. Documentation & Dossiers Oversee dossier preparation, submission, and re-registrations for international and domestic markets. Prepare documentation for product registrations, government tenders, and patent projects. Review artwork, promotional m...

B.Pharm / M.Pharm with 2 to 6 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle) Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents. Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

Role Description Implementing quality control and assurance processes ensure compliance with regulatory standards ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment. Health insurance Annual bonus Provident fund

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

To play a crucial role in upholding QA/AC/Regulatory Affairs standards & adherence to quality protocols. Commitment to excellence, contribute directly to our ability, deliver safe & effective products that meet customer expectations worldwide. Required Candidate profile Bachelor's in Pharmacy, Chemistry, Biology or related fields. Advanced degree preferred. 20+years of progressive experience in QA/QC/RA in nutraceutical or herbal extracts or Pharma industry.

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - E...