2122 Regulatory Affairs Jobs - Page 41

Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation pr...

Key Responsibilities: Market Development Expansion: Develop and implement business strategies for SE Asian markets. Conduct market analysis, competitor assessment, and feasibility studies to prioritize countries and product portfolios. Strategic Partner Management: Identify and appoint qualified distributors, agents, and institutional partners. Build strong long-term relationships and drive regular engagement to meet sales and regulatory objectives. Regulatory Affairs: Liaise with local regulatory consultants and ministries of health to ensure timely product registrations. Manage dossiers, artwork localization, and ensure compliance with each country s regulatory framework (e.g., BPOM, FDA P...

Urgent Job Opening Quality Assurance, Quality Control, Clinical Research , Regulatory Affairs, Medical Record Summarization , Medical Claims , Medical Officer, Medical Billing , Pharmacist, ADL, ARD, FRD, CDM, Production, R&D , Lab Technician

Key Responsibilities: Market Development Expansion: Develop and implement business strategies for SE Asian markets. Conduct market analysis, competitor assessment, and feasibility studies to prioritize countries and product portfolios. Strategic Partner Management: Identify and appoint qualified distributors, agents, and institutional partners. Build strong long-term relationships and drive regular engagement to meet sales and regulatory objectives. Regulatory Affairs: Liaise with local regulatory consultants and ministries of health to ensure timely product registrations. Manage dossiers, artwork localization, and ensure compliance with each country s regulatory framework (e.g., BPOM, FDA P...

Develop & maintain QMS documentation Ensure compliance with applicable quality standards and regulations Conduct internal audits & support external audits Work with CFT teams to resolve issues Train staff on QMS procedures

Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.

Medical Device Safety Physician – MBBS/MD mandatory. Review medical device safety reports (ICSR, SUSAR), assess risks, and ensure MDR/EU/US compliance. PV, clinical trials experience required. Required Candidate profile Strong decision-making, regulatory knowledge. WFO (Mumbai/Gandhinagar/Chennai/Pune/Indore). Salary up to 16 LPA.

Skills Required: • cross-functional coordination (FR&D, AR&D, RA, QA/QC) • Project timeline and milestone tracking • Knowledge of technology transfer and scale-up processes Understanding of regulatory documentation

Role & responsibilities : Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes) Participate and extend support during initial submission planning Review & update the list of documents required for the submission (e.g., NDA, variation, tenders) Manage compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes Preferred candidate profile :

Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Responsibilities may include the following and other duties may be assigned Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Devi...

1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken. 2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements 3. To liaise with cross functional teams to seek additional information 4. To ensure compliance to the agreements and be audit / inspection ready. 5. Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions 6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate corrective and preventive actions 7. ...

Part of Technology Transfer Team (Under R&D vertical ) at Palli location Responsible for Preparation of Master BMR, BPRs and document management. Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches. Responsible for reviewing GMP related documents. Responsible to select Equipment at Facility. To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes. To study critical parameters during scale up batches to optimize the CPPs and CQAs. To provide the i...

Job Summary: Experience in Drug identification number (DIN), natural health products (NHP), Dietary Supplement & Cosmetic notification submission and amendment notification to Health Canada. Experience in Formula review and approval. Evaluation of Ingredient as per Canadian Environmental Protection Act (CEPA) and Ingredient Listing creation including fragrance and flavor certificate review. Expertise in Artwork review and drive for approval. Change control management from initiation to approval in coordination with cross function teams and drive to implement the changes timely. Authoring Product Risk Management of self-care products. Experience in product website update and e-commerce activi...

To Support developing strategies to enter the market for the products in EU , Canada, Australia, Brazil etc. Independent supervision of all regulatory activities regarding dossier review, compilation, submission, approval and lifecycle management of the assigned products. Compilation and maintenance of regulatory documents in the supported business areas; Representation of Regulatory Affairs for SRA countries especially with regard to the regulatory requirements; Co-ordination with the CFT (QA/QC/RND/BD) team members to align the requirements and get it work done smoothly. Problem solving and strategic planning mindset are essential skills for this role with project management skills for col...

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Perks and benefits PF CANTEEN TRANSPORTATION

Privacy and Data Protection Director LocationIndia (preferably Bangalore) Experience - 16+ yrs Role dimension The Wipro Privacy and AI Governance Team is a dynamic group committed to maintaining the highest standards in privacy, data protection, AI governance and ethics. We operate at the forefront of these critical fields, ensuring that our practices align with both legal standards and technological advancements. We are seeking a dedicated and experienced professional to join our team as a Privacy and Data Protection Director. Job Summary As Privacy and Data Protection Director, you will play a pivotal role in embodying our privacy and data protection strategies across the organisation. You...

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Role & responsibilities Custodian of the packaging design and layout for all products Provides relevant source data for the Change Order/ Change Awareness notification Annotate the PDFs as per the respective Regulatory source content (word format) Clarify on need basis with the respective stakeholders, i.e. Labelling Lead, Artwork Coordinator, Market or Site Adherence to GSK artwork production standards and Standard Operating Procedures Identifies and engages other individuals who need to be involved in the review and approval of a Change Order, in accordance with any local procedures and requirements Participates in the review of the change on its viability on behalf of the market For chang...

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Cons...

The Red Hat Payroll team for Europe, the Middle East, and Africa (EMEA) is looking for a Payroll Analyst to join us in India. This role, you'll join a team that supports 31 Red Hat locations across EMEA. You will work in a fast-paced and complex environment that is deadline-driven. You'll report to the EMEA payroll manager and be responsible for ensuring the payroll is processed in an accurate and timely manner. What will you do: Prepare monthly payroll bureau submissions and review bureau-prepared payrolls for completeness and accuracy Process payments like net salaries to employees, tax payments, pension payments, etc. Manage month-end reporting of payroll general ledger Manage vacation ac...

Post- Legal Advisor No. of vacancy- 01 Job Location- Kandla, Gujarat Employment Type- Contract Exp Require- 5 to 10 yrs Min. Qualification- LLB with LLM Role & responsibilities Legal Compliance: Stay abreast of all relevant laws, regulations, and policies affecting the distribution company (Discom). Ensure the Discom's operations comply with local, state, and federal laws. Contract Review and Drafting: Review, draft, and negotiate various contracts, agreements, and legal documents. Provide legal advice on the implications of contract terms and conditions. Litigation Management: Manage and oversee any legal disputes, claims, or litigation involving the Discom. Collaborate with external legal ...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accent...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operati...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...