581 Ctd Jobs - Page 6

JOB Responsibility Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, ...

Please find the JD attached below for your reference.Position Scientific Writer / Regulatory WritingExperience- 3-5 Years Sr. Associate/ 7-9 Years – Lead / 10+ years- Associate ManagerLocation- Bang, Hyd, Mumbai, Pune, Delhi NCR (Hybrid-2 day WFO) Full time position Job Description – Regulatory Writing / Medical Writer : The Scientific and Medical content teams at work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy are...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory.Role & responsibilities Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

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...

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...

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...

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

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country o...

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...

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated

Support group reporting team in loading data onto HFM from onestream. Clearing validations at HFM / OS Preparation of control sheet OS to HFM walk on monthly basis Assistance during H1 / Annual group audit / FC1 and budget submission Migration of onestream to SAP etc. Requirements: Candidate must be pursuing CA course and eligible for industrial training as per ICAI internship guidelines Good exposure in accounting, taxation, financial analysis, and statutory audits during articleship period Strong understanding of IND-AS, Companies Act, and other relevant accounting standards Advanced proficiency in MS Excel (including financial modeling, pivot tables, VLOOKUP)

Your Role Take overall responsibility and project manage the implementation of travel products for clients. Document and track projects using client-specific processes and tools. Act as the single point of contact for the project team throughout the implementation process. Ensure adherence to the client-defined onboarding process, from pre-assessment to post-implementation. Lead local Joint Planning meetings and ensure effective collaboration. Clarify and communicate roles and responsibilities to all project members. Lead weekly conference calls, prepare agendas, and produce detailed call notes. Monitor project progress, ensure timely completion of tasks, and update project tracking tools (e...

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...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG: M.Pharma in Pharmacy

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...

Candidate should technically sound for assigned profile- Candiadte should have regulatory exposure in previous organisation

Role Description The Staff Accountant will be responsible for processing bank receipts and payments, and performing bank reconciliations. The role requires working effectively under tight deadlines, attention to detail, and high-quality analyses. The position reports to the Senior Accountant. Role and responsibilities Bank accounting receipts and payments (US/EMEA/APAC) Managing and creating bank payment runs Performing daily bank reconciliations Keeping track of all bank charges and interest cost Managing Month End Close for treasuring and banking, and related tasks like Bank module close, bank reconciliation, interest cost accruals, forex revaluation, etc. Formulate Standard Operating Proc...

End-to-end management of regulatory submissions for finished dosage forms. Prepare & compile high-quality dossiers (Modules 1–5). Coordinate cross-functional teams, handle queries, ensure compliance, and support lifecycle mgmt of products.

Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robust...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions and follow up on pending submissions. Stay updated with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work in a fast-paced environment and me...

Roles and Responsibility Publish regulatory submissions on time, ensuring accuracy and compliance with relevant regulations. Collaborate with cross-functional teams to prepare and review regulatory documents. Develop and maintain relationships with regulatory authorities and stakeholders. Stay updated with changes in regulatory requirements and implement necessary updates. Ensure all regulatory submissions meet required standards and quality criteria. Coordinate with internal teams to gather information and support for regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independ...