116 Actd Jobs

JOB DETAILS 1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master Files 2.Registration Dossiers & Technical Data Packages/OpenParts 3.In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation. 4.Prepare responses to deficiency letters received from various agencies for expeditious approval. 5.Preparation of Regulatory Amendments / Variations for smooth API supplies. 6.Provide regulatory support to cross functional departments. 7.Re-position of regulatory database and compliance to procedures FUNCTIONAL AREA Regulatory Affairs Executive jobs in hyderabad, Regulatory Affairs Executive...

Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker....

Responsibilities: * Manage regulatory compliance for Row Market products using CTD format under ICH guidelines. * Ensure timely submission of dossiers and variations in accordance with regulations.

Drug Regulatory Affairs will be responsible for compiling, reviewing, and submitting dossiers and regulatory documents for drug product approvals in international markets. Prepare, review, & submit (CTD/eCTD/ACTD formats) for new drug applications. Required Candidate profile B.Pharm/ M.Pharm in Life Sciences. 2–5 years of experience in Regulatory Affairs Knowledge of national and international regulatory (ICH,WHO,USFDA). Exp with dossier preparation in CTD/eCTD format.

Role & responsibilities 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 well-organized records of submissions, ...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Roles and Responsibilities (5 days working) Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries. Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions. Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries: New Product Registration, Re-Registration, Retention, Tender. Handling of queries from various regulatory authorities/consultants. Post Approval Changes GMP (Co...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, N...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Role Description: We are seeking a detail-oriented and globally minded Manager, Total Rewards to oversee the administration and execution of total reward programs, including employee benefits and equity plans for the Americas region. This role plays a key part in ensuring operational excellence, and an exceptional employee experience related to total rewards programs. The ideal candidate will have strong working knowledge of U.S. and LATAM total reward programs, experience leading teams, and a passion for delivering seamless reward operations. Roles & Responsibilities: Regional Program Administration (Americas) Manage the day-to-day administration of benefits programs (health, welfare, retir...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

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...

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

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

JD To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all CIS Countries and other country as per company requirements. Responsible for final review of dossier before submission To coordinate with technical team for documents required for dossier. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Provide responses to regulatory agencies regarding product information or issues. Impl...

Role & responsibilities Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across the world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary document...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...