2122 Regulatory Affairs Jobs - Page 22

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research...

Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures. Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc. Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licen...

Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA

Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Tr...

We are looking for a highly skilled and experienced Deputy Manager to join our team. The ideal candidate will have a strong background in management and leadership, with excellent communication and problem-solving skills. Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Lead and manage a team of professionals, providing guidance and support. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain relationships with key stakeholders and clients. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growt...

Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COAs and othe...

Role & responsibilities Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain wel...

Masters or PhD in Life Sciences, Pharmacy, Bioinformatics, Biomedical Engineering, or related field. 10-15 years of experience in Pharma IT, Life Sciences IT, or Bio IT, with strong exposure to both: Software product development (as product owner, architect, or program leader) IT services delivery (project/program management, client solutions, account growth) Deep understanding of drug development, clinical trials, pharmacovigilance, regulatory affairs, and digital health ecosystems. Demonstrated ability to launch and scale commercial products or platforms for regulated life sciences environments. Proven track record of delivering enterprise software solutions or IT services to global pharma...

We are seeking a highly skilled and detail-oriented Regulatory Affairs Executive / Senior Executive to join our dynamic team. The ideal candidate will have hands-on experience in applying for and managing regulatory licenses required for the import of raw materials and manufacturing of pharmaceutical, nutraceutical, and Ayurveda products. The role demands expertise in navigating Indian regulatory frameworks, including CDSCO, FSSAI, AYUSH , and obtaining Dual NOCs , Import Licenses , and product registrations . Key Responsibilities: Import Licensing & Raw Material Compliance Apply for and manage raw material import licenses through CDSCO or other relevant bodies. Coordinate with suppliers, fr...

Assist in site selection, initiation, monitoring, and close-out visits. Ensure that clinical trials are conducted in accordance with protocols, SOPs, GCP, and regulatory requirements. Verify the accuracy and completeness of case report forms (CRFs) and source documents. Maintain essential documents in the Trial Master File (TMF). Assist in resolving data queries and discrepancies with the site staff. Support investigators and site staff in trial-related activities. Participate in project team meetings and training sessions. Prepare visit reports and follow-up letters. Maintain regular communication with study sites to ensure compliance and timely data entry.

Role Overview The Head QA/RA will be responsible for leading Regulatory Affairs (RA) and Quality Assurance (QA) functions to ensure compliance with Indian & International medical device regulations (MDR 2017, EU MDR 2017/745, US FDA 21 CFR, ISO 13485). This role will be pivotal in driving product approvals, managing audits, and maintaining the highest standards of product quality and regulatory compliance. Role & responsibilities Regulatory Affairs (RA): Submission of documents to State FDA & CDSCO, New Delhi for approval of additional domestic/export products. Renewal of Drug Manufacturing License as per statutory requirements. Arrange FSC, Non-Conviction Certificate, QMS Certificates from ...

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.

Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Labeling Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Dete...

To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment. To give regulatory support to project teams, stakeholders and other sites, as require How you ll spend your day Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation ...

Support EU Generics Labeling Managers and Labeling Germany Managers in providing pharmaceutically and medically accurate product labelling, especially for multiple regulatory procedures of one INN. Manage translations for Centralized Procedures (CPs). How you ll spend your day Editorial Tasks Perform various editorial tasks. Review of SmPC and PIL as well as packaging materials using a review protocol. Adapt texts to the current QRD template. Proofread texts. Prompt provision of product information and comments in regulatory database (GRIDS). Responsibilities under the role of super-editor (GRIDS). Coordinate and handle inquiries from other departments, locations, and service providers. Scre...

Role & responsibilities Responsible for overseeing all aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leadi...

Roles Open: QA (QMS, Validations and AQA): Qualifications, Process/Cleaning Validation, QMS (Change Controls, Deviations, CAPA, Complaints, and OOS) RA (Regulatory Affairs): CTD Preparation/Review, Regulatory Queries, Tech Transfer Documents. Required Candidate profile QA Executive / Sr. Executive (QMS & Validations) AQA Executive / Sr. Executive (Analytical QA) RA Executive / Sr. Executive – Regulatory Affairs

Role : Assistant Manager Scientific Communications Location : Mumbai/Gurgaon/Chennai Job Responsibilities Deploy the local Scientific Communication strategy Develop/adapt all scientific communication materials and training modules for the local market Develop and present technical/product/nutritional presentations to key internal and external stakeholders to disseminate information regarding Royal Canin, products and Health Thru nutrition Provide technical/product support to key areas of the business including Consumer Care, Regulatory Affairs and Marketing/Sales/Digital teams Influence customers through trainings to recommend specific territories / products of Royal Canin. Help in deploying...

About this role: Wells Fargo is seeking a Senior Quality Assurance Administrator. In this role, you will: Provide support and scoring guidance quality assurance staff by answering questions on regulations or compliance, procedures, policies and First Call Resolution Escalate key maintenance errors identified during scoring process and ensure resolution of same, reviewing programs, processes, documentation, to ensure compliance with internal company requirements or government regulations Review systems to ensure company standards are met, exceptions are notated, and issues escalated as necessary Assist in development and design of product specific databases Review and score work Prepare calib...

Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation ...

Job description Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10-15yrs. with dossier submission experience in South East Asia (Malaysia, Philippines, Thailand, Vietnam , Singapore, Lebonon, Hongkong, Brunei and Middle-East (UAE,/soudi,Iraq) Experience of regulatory submissions and life cycle management of SEA and MENA region. Interested candidate can share cv on creyesha.macwan@alembic.co.in

Role & responsibilities Develop the regulatory compliance strategy / framework / compliance checklists for the various Centers of the company.Obtain all relevant licenses for Green field projects Verify all licenses of Brown field projects and support BD team in getting right licenses - Read and interpret all the relevant acts and rules and prepare the procedures, forms, formats for obtaining regulatory clearances, licenses and permissions - Keep track of all the changes in the various applicable laws, acts , rules and modify the existing processes, forms , procedures in alignment with the changes in the laws - Work with Field / Geography teams for obtaining all the necessary regulatory perm...

Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Canada market for CMC and labelling aspects. Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines. Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities Co-ordinate with cross functional teams for document request, review, required for regulatory submission Upload and publish the documents in eCTD software required for regulatory submission Arranging and coordinating trainings within departments

Lead the preparation, review, and submission of high-quality regulatory CMC documentation for Canada market. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs) Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities Review of change controls and categorize the changes as per the guideline requirements with the clear communication of documentation requirements Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations ...

We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.