3203 Regulatory Affairs Jobs

It responsible for executing sustainability duties at the global level within the Flavour and Fragrance business unit. Required Candidate profile Navi Mumbai. global implementation of SR compliance, guidance of the Global SR and Regulatory Manager, global standards, collaboration, regulatory documentation., compliances

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Responsibilities: * Ensure compliance with global regulations * Manage regulatory submissions & approvals * Collaborate with cross-functional teams on product launches * Maintain regulatory knowledge & best practices

Description Amazon Web Services (AWS) is a fast-paced technology company and the leading provider of hyper-scale public cloud computing services. Our policy scope is broad, forward-thinking, and consistently focused on customer benefit. We are at the forefront of helping customers maximize the benefits of cloud computing and AI by promoting innovation friendly policies. Are you ready to apply your skills and experience in public policy development and advocacy in the fast moving, transformational sector of cloud computing and information technology We are looking for a talented, innovative, and motivated public policy professional with demonstrated ability to contribute to and support Govern...

Description Amazon Web Services (AWS) is a fast-paced technology company and the leading provider of hyper-scale public cloud computing services. Our policy scope is broad, forward-thinking, and consistently focused on customer benefit. We are at the forefront of helping customers maximize the benefits of cloud computing and AI by promoting innovation friendly policies. Are you ready to apply your skills and experience in public policy development and advocacy in the fast moving, transformational sector of cloud computing and information technology We are looking for a talented, innovative, and motivated public policy professional with demonstrated ability to contribute to and support Govern...

Job Profile: Regulatory Affairs Manager Experience: 10+ years Location: Delhi NCR Industry: Medical Device/ Pharma Job Description: Regulatory Affairs & Quality Compliance (MDR 2017) End-to-end management of regulatory dossiers, licensing, renewals, labeling compliance, and post-market surveillance. Cross-Functional Coordination Ensures product lifecycle compliance, including change control and audit readiness. Issue & Risk Management Leads regulatory audits, manages non-compliance, and drives quick resolution of critical issues. Government Liaison Strong engagement with regulatory authorities, ministries, NPPA, CPCB, DOP, BIS, and Materiovigilance. Policy & Advocacy Tracks regulatory develo...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 world's largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, s...

- Daily updating of the trackers, tracking submitted applications for India, updating team on queries, new notifications received & daily dispatches if any. - Archival for documents like approvals, query letters etc in appropriate manner - Sharing NMRA updates. - Support operational activities for product registrations in India for Communicable Diseases, Metabolics, Neurology and Established Products portfolio- Making complete dossiers and query responses within specified timelines - Coordinate with global team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration. - Support operational activities for lifecycle management Comm...

Timely submission of registration application and subsequent query responses. Make local administrative documents as necessary for submission, draft artwork manuscripts for new products, complete LLD process when required. Liase with global team & local SC team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration Responsible for timely renewals and CMC variations To prepare, draft, collate various applications as necessary as a part of product registration maintenance activity Asist in all activities pertaining to the clinical trial. Responsible for maintaining required internal and external compliance standards. Cross functi...

The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management. Roles & Responsibilities: System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, eff...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description RCR Specialist (Admin), Regulatory Compliance Review, Regulatory Affairs Perform global regulatory compliance review of essential documents supporting the customization of study-specific Essential Document Checklists Respond to project teams on queries on Essential Document Checklist requirements Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Essential Document Checklist Process Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as ap...

Role Summary The Legal Counsel - Compliance will support the Legal & Compliance team in managing and monitoring India-level and global compliance requirements for AM/NS. This role involves ensuring adherence to applicable laws, regulations and internal policies, while coordinating with cross-functional teams and external stakeholders to implement, oversee and maintain a robust compliance framework. Job Responsibilities I. Strong understanding of Indian laws and global compliance requirements and trends, to support implementation of India and global compliance tools and programs (e.g., anti-bribery, anti-corruption, whistleblower, sanctions check, data privacy). II. Assist in drafting and rev...

Job Summary: Responsible for directing all legal, compliance, and regulatory affairs of the organization, supporting strategic decision-making and ensuring full adherence to applicable laws and corporate governance standards. This role holder will leverage deep industry and regulatory knowledge to build robust legal frameworks and compliance programs. Key Responsibilities: Serve as primary legal advisor to executive management and board, providing expert guidance on corporate, commercial, regulatory, and legal compliance matters. Develop, implement, and oversee comprehensive legal programs, ensuring the company adheres to statutory and regulatory requirements, including SEBI, Companies Act, ...

The EU REACH Coordinator is responsible for ensuring compliance with the EU REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation. This role involves managing registration, documentation, and compliance processes for chemical substances used in the company s products. The coordinator will work closely with regulatory authorities, internal departments, and external partners to ensure all chemical substances meet required safety and compliance standards. Key Duties & Responsibilities Regulatory Compliance Ensure the company s compliance with EU REACH regulations by managing registration, evaluation, and authorization processes. Monitor REACH regulatory update...

Job Title Regulatory Affairs Specialist Job Description Job Title : Regulatory Affairs Specialist Job Responsibilities: Monitors global regulatory changes, interprets requirements, and integrates findings into regulatory strategies, ensuring timely communication with teams. Implements regulatory strategies for international markets, collaborating with cross-functional teams to align plans with organizational objectives and ensure compliance. Manages product registration and commercialization processes, preparing and submitting regulatory documents, coordinating with regulatory bodies, and ensuring accuracy and timeliness. Reviews regulatory documentation, validates marketing materials, and e...

Experienced QA professional for medical device (IOL) manufacturing. Must have strong knowledge of ISO 13485, CE certification, and international regulatory standards. Experience in documentation, audits, and device licensing preferred. Required Candidate profile Candidates with 0–5 yrs QA experience, hands-on with audits, documentation & regulatory submissions.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 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 You will be aligned ...

-Contribute to the development of public policy positions for AWS and lead and drive advocacy with senior policy officials in Government Departments and Agencies. -Assess and communicate the implications of potential regulatory actions, identify public sector business opportunities of government initiatives, develop enhancement or mitigation strategies to policy proposals, and coordinate advocacy efforts, outreach programs and the communication of key AWS business initiatives. -Manage and coordinate external advocacy efforts, outreach programs and key initiatives in concert with AWS business objectives, working closely alongside colleagues in India and globally. -Collect and verify intellige...

Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support delivery (on time and within the budget) of developed purification processes and of clinical batches of purified recombinant proteins Responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for scale-up and GMP production Expertise in downstream process development of large molecules recombinant protein and monoclonal antibodies. Proficient in handling of chromatographic systems. Candidate should possess sound knowledge of operating the TFF system, filtration system and should be ...

1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Pre...

Qualification :MSc in Chemistry, Organic Chemistry, Molecular Chemistry 5 to 7 years in API Manufacturing (Active Pharmaceutical Ingredients) Job Role :- Assist in development, implementation, and maintenance o

Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry for filing of products in various regulatory agencies Knowledge: Strong understanding of regulatory guidelines and

•Deep understanding of Indian Automotive regulations CMVR, BIS, AIS •Participation in Technical Regulatory committees within SIAM and external agencies on upcoming Safety Regulations discussions •Familiarity with regulatory bodies and committees .

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

We are seeking a diligent Regulatory Affairs specialist to support our compliance efforts, ensuring adherence to FSSAI, Legal Metrology, and AYUSH regulations. The successful candidate will play a key role in preparing and submitting statements for new product endorsements, license renewals, and quarterly/annual returns, maintaining strict regulatory compliance. Key Responsibilities: FSSAI Compliance: Review formulations and packaging to ensure alignment with FSSAI guidelines, manage product endorsements via the FOSCOS Portal, and provide recommendations for necessary modifications to meet compliance requirements. Artwork & Labeling Compliance: Validate and coordinate changes in product form...