161 Fda Jobs - Page 7

Hi We are hiring for Regulatory Submissions Publisher. Please go through the JD and Apply Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor 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 - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Commitment to quality Agility for quick learning Adaptable and flexible Ability to work well in a team Ability to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

"Seeking a QA to ensure regulatory compliance (FDA, ISO, CE), manage quality assurance processes, conduct audits, maintain documentation, and collaborate cross-functionally. 3-5 years experience in regulatory affairs and quality management required."

B.Pharm / M.Pharm with 8 to 10 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

We are seeking a highly skilled Quality Control Chemist to join our team in Ahmedabad. The ideal candidate will be responsible for testing and analyzing raw materials, in-process samples, and finished cosmetic and skin care products to ensure compliance with regulatory and company quality standards. This role requires strong analytical skills, hands-on experience with laboratory equipment, and a keen understanding of cosmetic formulations and Good Manufacturing Practices (GMP). Key Responsibilities: Conduct quality control tests on raw materials, bulk formulations, and finished cosmetic and skincare products. Perform instrumental analysis using HPLC, GC, FTIR, UV Spectrophotometry, and other laboratory equipment. Ensure compliance with GMP, ISO, and FDA guidelines for cosmetics and personal care products. Maintain stability study programs and analyze product performance over time. Conduct microbiological and physicochemical testing to verify product safety and efficacy. Develop, validate, and execute Standard Operating Procedures (SOPs) and analytical test methods. Identify and troubleshoot any quality deviations or formulation inconsistencies. Assist in the development of new formulations and improvement of existing cosmetic products. Collaborate with R&D, production, and regulatory teams to ensure overall product quality. Prepare and maintain detailed reports, documentation, and quality records for audits. Required Technical Skills & Qualifications: Education: B.Sc./M.Sc. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Freshers/Experience: 2-5 years of experience in a cosmetic, skin care, or personal care manufacturing QC lab. Strong knowledge of analytical chemistry techniques and laboratory best practices. Hands-on experience with analytical instruments such as HPLC, GC, UV, and FTIR. Familiarity with regulatory requirements (GMP, FDA, BIS, ISO 22716) for cosmetics and personal care products. Ability to analyze and interpret test results, batch records, and quality data. Proficiency in MS Office (Excel, Word, PowerPoint) for documentation and reporting. Strong problem-solving skills and attention to detail. Effective communication and team collaboration skills. Preferred Qualifications: Experience with microbiological testing and contamination control in cosmetics. Knowledge of stability testing protocols for skincare and personal care products. Understanding of color, fragrance, and texture analysis in cosmetic formulations. Ability to work in a fast-paced manufacturing environment and meet deadlines. Salary & Benefits: Competitive salary based on experience and qualifications. Performance-based incentives. Opportunities for professional growth and training. Health and wellness benefits.

We are seeking a highly skilled Factory Operations Manager to oversee and optimize daily manufacturing operations at our Ahmedabad facility. The ideal candidate will be responsible for production planning, process efficiency, quality control, compliance, and overall plant management to ensure smooth operations and maximum productivity. Key Responsibilities Production Management: Oversee manufacturing processes to ensure timely and cost-effective production while maintaining quality standards. Process Optimization: Implement lean manufacturing principles to improve efficiency, reduce waste, and enhance productivity. Quality Assurance: Ensure all products meet regulatory and quality standards, working closely with the QA/QC team. Compliance & Safety: Enforce safety protocols and ensure adherence to government regulations and company policies. Team Leadership: Manage and supervise factory staff, including production supervisors, machine operators, and workers. Inventory & Supply Chain Coordination: Monitor raw material inventory, coordinate with procurement, and ensure smooth supply chain operations. Maintenance & Troubleshooting: Oversee equipment maintenance and address technical issues to prevent production downtime. Reporting & Analysis: Prepare production reports, track KPIs, and suggest improvements for operational efficiency. Qualifications & Experience Bachelor?s or Master?s degree in Engineering, Manufacturing, Operations Management, or a related field. 7+ years of experience in factory operations, preferably in the skincare, cosmetics, or pharmaceutical industry. Strong knowledge of GMP, ISO, and FDA regulations. Proven leadership skills with experience in managing factory teams. Excellent problem-solving, decision-making, and analytical skills. Proficiency in production planning tools and ERP software is a plus. Why Join HCP Wellness? Opportunity to work with an innovative and growing company in the beauty and personal care industry. Competitive salary and benefits. Professional growth and leadership development opportunities.

* Experience of GC -HPLC & all Lab INSTRUMENTS. * Documentary work, SOP preparation & Handling all Lab activity. * ISO, GMP, FDA, WHO Audit Faced * Having an instrumental and wet lab. Required Candidate profile * Implement & monitor good documentation practices to ensure data traceability. * Investigate customer complaints related to API quality and coordinate corrective & preventive actions (CAPA).

Skill required: Quality Governance & Services - Operational Audit & Compliance Designation: Quality Assurance Analyst Qualifications: BE/Bachelor of Pharmacy/Bachelors of Information Technology Years of Experience: Minimum 2 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 - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.You 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 and education, policies and procedures, quality assurance, patient services, and public relationsThe Operational CSV team focuses on validation of computerized system applications and effective implementation and delivery of functional processes within operations to mitigate risks. The role may require for you to have a good understanding of software tools, GAMP Gudiance, 21 CFR and EU Regulations and hands experience on Validation of Enterprise applications What are we looking for? Information Management System Testing and Validation Adaptable and flexible Ability to meet deadlines Ability to establish strong client relationship Prioritization of workload Problem-solving skills Life Sciences Automation Enablement Life Sciences CSV Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Responsible for supporting and/or conducting validation efforts for Accenture projects. These projects include system implementation, development of non-commercially available systems, deployment of managed hosted systems, validation of systems, and decommissioning of systems. Responsible for project management of the effort. Responsible for authoring or coordinating the authoring of applicable documentation to ensure adherence to current FDA regulations and industry standards: test scripts/checklists (IQ/OQ/UAT), Requirements Specification, Traceability Matrix, System Validation Master Plan, Final Validation Report, etc. Responsible for participating in and contributing to team meetings and fostering knowledge exchange within the Validation Team and with other colleagues. Responsible for mentoring more junior members of the Validation Team. Qualifications BE,Bachelor of Pharmacy,Bachelors of Information Technology

Seeking Sr. RA Specialist for Product Environmental Compliance. Expertise in medical device regulations, BOMCheck, environmental reporting, and compliance. 5+ years experience in regulatory or product environmental compliance within medical devices

Position: Manager Grade : G10 Job Location : Gurgaon (preferable)/Baroda/Mumbai Education : M. Pharm Department : Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product team member and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA , original NDA/MAA , agency background packages and responses to health authority questions per established business processes and systems. Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills: Hands of expertise of preparation & review of dossiers , response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Education Minimum Requirement: M-Pharm in pharmaceutical sciences Required Experience and Skills: 5-12 years of hands-on experience in regulatory affairs This role needs a seasoned professional who is aware of the regulatory activities for NDAs , can work in R & D CFT and who has the management capability of leading a group of team members The candidate must be proficient in English; additional language skills are a plus. Good inter-personnel skills with ability to direct multi-departmental functions.

Job Overview: The Business Development Engineer will be responsible for driving growth in the ventilator product line, identifying and creating new business opportunities, and establishing relationships with key stakeholders in the healthcare sector. The ideal candidate will have a strong background in medical device engineering, specifically within ventilator technologies, along with business acumen to navigate the medical field. Key Responsibilities: Market Analysis & Strategy Development: Conduct thorough market research to identify potential business opportunities in the ventilator market, both domestically and internationally. Develop comprehensive business strategies based on market trends, customer needs, and competitive landscape. Sales and Business Growth: Drive sales efforts and support the sales team in promoting ventilator products to hospitals, clinics, and medical institutions. Help expand our customer base by identifying and nurturing relationships with key stakeholders and decision-makers in the healthcare industry. Product Expertise & Technical Support: Leverage technical knowledge of ventilator systems to offer solutions and support to potential customers. Assist in product demonstrations, presentations, and provide product training as necessary. Collaboration with R&D and Engineering Teams: Work closely with the R&D and engineering teams to communicate customer needs and help guide product enhancements or new features. Ensure product offerings align with regulatory standards and customer requirements. Regulatory Knowledge: Stay updated on relevant medical device regulations, certifications, and standards. Support the development of required documentation for regulatory submissions and compliance with medical device regulations (e.g., FDA, CE marking). Networking & Partnerships: Attend industry conferences, trade shows, and other relevant events to promote the company's products, build professional networks, and forge partnerships with key medical organizations. Reporting & Feedback: Provide regular reports on sales targets, market trends, and customer feedback to senior management. Contribute insights to improve overall product development and marketing strategies. Qualifications: Educational Background: Bachelor's degree in Biomedical Engineering Experience : Minimum of 3-5 years of experience in medical device industry, with a strong focus on ventilators. Technical Expertise: In-depth understanding of ventilator technologies, mechanical systems, and electronic components, as well as knowledge of relevant regulatory standards in the medical device industry. Skills: Excellent communication and negotiation skills. Ability to engage with technical and non-technical stakeholders. Strong problem-solving skills and the ability to translate technical features into customer benefits. Proficient in Microsoft Office Suite and CRM tools. Other Attributes: Self-motivated, driven, and results-oriented with a passion for the medical field. Ability to work independently and as part of a cross-functional team. Travel may be required. For more Information contact 9160249222