392 Fda Jobs

Job Title: Regulatory In-charge (Semi-Regulated Markets) Company: GenAide Pharmaceutical Pvt Ltd Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060 About GenAide Pharmaceutical Pvt Ltd: GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey! Experience: 5 - 6 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seekin...

Technical Comparisons: Conduct thorough evaluations of biomedical equipment and technologies to provide insights and recommendations for procurement and upgrades. Assess performance, safety, and cost-effectiveness of existing and new biomedical devices. Carry out Preventive , Corrective & Breakdown Maintenance , day-to-day departmental activities, including project management, equipment maintenance, and troubleshooting. Collaboration: Work closely with clinical staff, vendors, and regulatory bodies to foster collaboration and effective communication regarding biomedical equipment and safety practices. Roles and Responsibilities Technical Comparisons: Conduct thorough evaluations of biomedica...

As a Regulatory Affairs Consultant - Head, you will leverage your minimum of 10 years of Life Science industry experience to provide substantial expertise in regulatory affairs. Your hands-on experience in Chemistry, Manufacturing, and labeling processing will be crucial in ensuring compliance with global regulatory standards such as FDA, EMA, ICH, and other international regulations. Your excellent communication skills, both written and verbal, will be essential in effectively conveying regulatory requirements within the organization. Key Responsibilities: - Demonstrating expertise in CMC and labeling processes - Ensuring compliance with global regulatory frameworks including FDA, EMA, and ...

Version 1 is currently seeking a JD Edwards CNC Consultant to join our team. This job will be within projects team at Version 1, and it is focused on the technical support of JDE Edwards installation and upgrade projects. The candidate will be expected have sufficient experience in JDE Tools and Application Updates, JDE release upgrades and new installs. The candidate will also be expected to be able to manage tickets within the managed service for various issues with key skills being the ability to manage and administrate JDE environments with tasks such as system checks, package builds, patches and upgrades, troubleshoot issues, and provide technical support to end-users. Responsibilities ...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem...

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem ...

Conduct quality checks of raw materials, in-process, and finished goods Maintain QC documentation and test records Assist in audits and ensure compliance with standards Coordinate with production for quality improvements Required Candidate profile Job Title: Quality Executive Location: Merta, Rajasthan Experience: 2–4 Years Salary: 30,000 – 35,000/month Type: Full-Time Industry: [Manufacturing/FMCG/Pharma] Joiners: Immediate preferred

Main Objective of the Role To maintain sufficient stock of material required for day to day surgeries. Knowledge Inventory Management, Re-Order Level of stock, ABC Analysis, Product knowledge, HIS operating knowledge. Skills Team building skills Analytical and problem solving skills Decision making skills Effective verbal presentation and listening communications skills Good interpersonal and communication skills People oriented Skilled and competent Understanding about product quality & Market Price Integrity and Ethics Adaptability / Can do attitude Believe in Knowledge Distribution Key Responsibilities Follow up with the Central Stores for supply of ordered material in order to maintain a...

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work. Education: Postgraduate in Master of Business Administration (Pharmaceutical Management) Graduate in Pharmacy Experience: 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products

Key Responsibilities Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices . Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1). Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation). Support risk management , cybersecurity compliance , and software lifecycle documentation . Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements. Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions. Required Skills & Exp...

Key Responsibilities Lead end-to-end product development for plastic components and assemblies . Drive material selection considering performance, cost, compliance, and sustainability. Create 3D CAD models and detailed 2D drawings with GD&T for production. Perform Moldflow/FEA simulations to optimize designs for manufacturability and reliability. Collaborate with toolmakers/suppliers for injection molding tool design, review, and validation . Resolve tooling and production issues (warpage, sink marks, shrinkage, weld lines). Ensure compliance with industry standards (UL, ISO, RoHS, REACH, FDA if applicable). Support prototype development and testing (3D printing, CNC, soft tooling). Conduct ...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Job Description: FDA Manager Food/FMCG (15-20 yrs) Position: FDA Manager Department: International Business Timings: 12:00 Pm to 9:00 pm We are looking for a seasoned US FDA Clearance Manager with 1520 years of experience in Regulatory Affairs & Compliance for Food/FMCG, with a strong focus on the US market. Key Responsibilities: Lead all USFDA clearance, approvals & compliance processes. Ensure adherence to 21 CFR, FSMA, FSVP, labelling & packaging norms . Manage dossiers, regulatory submissions & audit inspections. Guide cross-functional teams (R&D, QA, Production, Exports). Liaise with USFDA, certification bodies, distributors & consultants. Qualification & Experience Degree in Food Tech/...

Role & responsibilities Minimum of 10 years of Life Science industry experience, with substantial exposure to regulatory affairs. Hands on experience and demonstrated expertise in Chemistry, Manufacturing, and labeling processing Comprehensive understanding of global regulatory framework, including FDA, EMA, ICH and other international standards. Excellent communication skills both written and verbal Meticulous attention to detail and organizational prowess Proficiency in project management and cross-functional collaboration Strong analytical and problem-solving skills Ability to navigate and interpret complex regulatory landscapes across multiple regions Good understanding of Quality Manage...

Work Flexibility: Hybrid What will you do : Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Supply Chain, Manufacturing) to execute product transfers. Responsible for process development and all process documentation (SOPs, Work Instructions, BOMs, Routers, PFMEAs, Control Plans) is reviewed, updated, and transferred Prepare and review PPAP documents (PFMEA, Control Plans, Process Flow Maps, , Process Capability Study, inspection plans etc) and support method qualifications Develop and qualify gages: perform Gage R&R and MSA studies Review and qualify manufacturing processes, ensuring regulatory and quality compliance Coordinate with supplier quality and sourcing t...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

The team focusing on Healthy Aging through AI is looking for a talented individual to join their 2019 X-ray AI project under the Global Business Team. The team, led by the CEO, is at the forefront of innovation in healthcare technology, aiming to revolutionize the industry through cutting-edge AI solutions. As a member of this team, your main tasks will include collaborating with Key Opinion Leaders (KOL) to drive the project's success. You will be responsible for setting and achieving key performance indicators (KPI) related to Regulatory Affairs/Quality Assurance (RA/QA), Research and Development (R&D), and more. The ideal candidate for this role should be an Osteo Signal Global Game Chang...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the needs outlined by physicians. You will be responsible for assuring quality care by adhering to standards set by the physicians. Additionally, you will provide care education to patients in person or over the phone and adhere to compliance guidelines throughout processes (OSHA, FDA, HIPAA). To qualify for this position, you must be a Registered Professional Nurse with current licensure. It is also required to have CPR, ACLS, and BCLS Certification. Knowledge of OSHA, FDA, and HIPAA compliance is essenti...

Exp. in Biopharmaceuticals Biosimilars consulting and strategy oriented projects Strong foundation in pharmaceutical and drug dev. lifecycle understanding of commercialization process, or Biopharmaceuticals o Excellent communication skills

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :1 to 6 yrs Work Location :Pan India Required Skills : CNC Admin Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :3 to 8 yrs Work Location :Pune/Mumbai/Hyderabad Required Skills : JDE Technical Interested candidates can send resumes to nandhini.s@spstaffing.in

Position Summary: We are looking for an experienced R&D Engineer Trainer with 1015+ years of expertise in the medical device industry . This role will focus on leading training programs in the design , development , and optimization of innovative medical technologies . The trainer will provide guidance on the full new product development (NPD) lifecycle from concept through commercialization while ensuring alignment with global regulatory requirements. The position also involves close cross-functional collaboration to support the delivery of safe, effective, and high-quality medical devices that enhance patient outcomes. Key Responsibilities: Lead the design and development of new medical de...