3208 Regulatory Affairs Jobs - Page 11

Coordinate and manage shipping operations, including arranging transportation and logistics.Develop and maintain relationships with clients, suppliers, and other stakeholders.Prepare and review shipping documents Required Candidate profile Strong knowledge of shipping regulations, laws, and practices. Excellent communication, negotiation, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines.

Publish regulatory documents accurately and efficiently.Ensure compliance with industry standards and regulations.Collaborate with cross-functional teams to meet business objectives Required Candidate profile Strong understanding of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independently and as part of a team

Conduct thorough medical device safety assessments and evaluations. Develop and implement effective safety protocols and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Strong knowledge of medical devices and their safety regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment.

Develop high-quality aggregate reports related to pharmacovigilance. Conduct thorough research and analysis to identify trends and patterns in medical data. Collaborate with cross-functional teams to ensure timely delivery of reports. Required Candidate profile Minimum 2 years of experience in medical writing, preferably in pharmacovigilance or aggregate reporting. Strong knowledge of pharmacovigilance principles and regulations.

Develop high-quality aggregate reports related to pharmacovigilance. Conduct thorough research and analysis to identify trends and patterns in medical data. Required Candidate profile Minimum 2 years of experience in medical writing, preferably in pharmacovigilance. Strong knowledge of aggregate reporting principles and practices.

Manage and oversee clinical study data management activities, ensuring compliance with regulatory requirements. Develop and implement effective data management plans to ensure data quality and integrity. Required Candidate profile Strong knowledge of clinical trial regulations and guidelines, including GCP and ICH. Experience with data management systems, such as Oracle or SQL.

Manage and oversee daily card operations activities. Ensure compliance with regulatory requirements and industry standards. Develop and implement process improvements to enhance efficiency and productivity. Required Candidate profile Minimum 2 years of experience in a related field, preferably in employment firms or recruitment services. Strong knowledge of French language is required.

Coordinate and conduct clinical trials, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to develop and implement study protocols. Required Candidate profile Strong knowledge of clinical trial regulations, GCP guidelines, and ICH guidelines. Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.

Manage shipping operations for timely and efficient delivery. Coordinate with logistics teams to resolve issues and enhance service quality. Develop and implement strategies to improve shipping costs and reduce delays. Required Candidate profile Minimum 5 years of experience in shipping or logistics management. Strong knowledge of shipping regulations and industry standards. Excellent communication and problem-solving skills.

Coordinate and manage shipping operations, including arranging transportation and logistics. Develop and maintain relationships with clients, suppliers, and other stakeholders. Prepare and review shipping documents. Required Candidate profile Strong knowledge of shipping regulations, laws, and practices. Excellent communication, negotiation, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines.

Responsibilities. Global Product Registration & Dossier Management Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries. Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats. Serve as the primary Point of Contact (POC) to coordinate data between R&D, factory, customers, and regulatory authorities for seamless submissions. Compliance and Policy Monitoring Monitor global regulations (e.g., MRLs, restrictions) and communicate changes to ensure continuous company compliance. Verify GLP/quality compliance of all required efficacy, toxicity, and environmental studies prior...

JOB TITLE: Medical Device Regulatory Compliance Specialist JOB SUMMARY: We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to play a critical role in ensuring our medical device development processes meet the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience with technical documentation, quality systems, and regulatory submissions, and will play a key role in ensuring product safety and compliance throughout the development lifecycle, specifically focusing on the Design History File (DHF) and Device Master Record (DMR). RESPONSIBILITIES: Support the preparation and maintenance of USFDA and EU MDR-comp...

Conduct thorough reviews of clinical data to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve data discrepancies. Develop and implement effective data management strategies Required Candidate profile Strong understanding of clinical data review principles and practices. Excellent analytical and problem-solving skills with attention to detail. Effective communication and interpersonal skills

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards and regulations. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and edit regulatory documents Required Candidate profile Experience in regulatory submissions publishing, preferably in the employment or recruitment industry. Strong understanding of regulatory requirements and guidelines governing submissions.

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services. Excellent communication and coordination skills. Ability to work effectively in a fast-paced environment. Strong analytical skills.

Conduct thorough medical device safety assessments and evaluations. Develop and implement effective safety protocols and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze data and trends Required Candidate profile Strong knowledge of medical devices and their safety regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment. Strong communication

Conduct thorough analysis of clinical trial data to identify potential safety concerns. Develop and implement effective safety protocols to mitigate risks associated with medical devices. Collaborate with cross-functional teams Required Candidate profile Strong understanding of clinical trials, medical devices, and regulatory requirements. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment.

Candidate should be well-versed with Regulatory guidelines, US-FDA, Health Canada, EMA Compilation, review and submission of ANDA, Controlled correspondences, Scientific package to USFDA and responding to queries. Suggest regulatory pathway during development phase for ANDAs. Handling of product life cycle changes and guide cross functional team for filing strategy Review of DMFs., PDR, Labelling and other product related documentation for ANDA. Establishment registration, re-registration, and submitting annual updates

Develop high-quality aggregate reports on medical data, including patient safety and efficacy.Conduct thorough analysis of medical records to identify trends and patterns.Collaborate with cross-functional teams to ensure accurate Required Candidate profile Minimum 2 years of experience in medical writing, preferably in Pharmacovigilance. Strong knowledge of medical terminology, regulations, and industry standards. Excellent writing, communication,

: Execute audit strategy and plan of concurrent audits testing in accordancewith the Policies, Procedures, Legal, Statutory and Regulatory requirements, Internal Audit Standards, and leading best practices. Maintain and update concurrent audit procedures and checklists to ensure they remain current and updated keeping pace and aligned with changes in internal policies/guidelines as well as legal/statutory/regulatory changes and evolving industry best practices. Ensure timely and quality execution of concurrent audit reviews . Ensure timely completion of Concurrent audit plan with quality of audits, and meet with all concurrent audit documentation and reporting requirements as per Concurrent ...

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability to work independently and as part of a team.

Preferred candidate profile Qualifications/ JD: Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field. In-depth understanding of medical device regulations, including FDA 21 CFR Part 820.30 and ISO 13485:2016 requirements for design controls and DHF. Experience with risk management principles (e.g., ISO 14971) and their application to DHF. Experience with DHF remediation projects, especially for legacy products and/or in response to regulatory changes. Experience with Quality Management Systems (QMS) software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.

Key Responsibilities: • Develop and align quality strategies across plant locations ensuring compliance and product consistency. • Oversee QA/QC with adherence to GMP and global regulatory requirements. • Lead audits, inspections, and regulatory interactions. • Drive continuous improvement using Six Sigma, Lean, and other QMS frameworks. • Build and mentor strong quality teams across sites. • Track and analyze Quality KPIs (FPY, supplier defects, COPQ, regulatory observations). • Collaborate with Plant Heads, Production, R&D, Supply Chain, and Regulatory Affairs for synchronized quality efforts. Required Qualifications: • Bachelor’s/Master’s in Pharmacy, Chemistry, Engineering, or related sc...

This is an exciting role and would entail you to • Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats) • Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR/Submission managers • Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines • Annotate any notes/comments relevant to MLR reviewers onto the submission file (As required, f...

As a Production Chemist specializing in the formulation and production of nutraceutical and Aayush products, your role will involve the following key responsibilities: - Develop and optimize formulations for nutraceutical and Ayush products, such as tablets, capsules, and liquid dosage forms. - Conduct scale-up studies from lab to production scale while ensuring compliance with regulatory standards. - Prepare and manage comprehensive bill of materials for all products, ensuring accurate documentation of raw materials, quantities, and suppliers. - Oversee the production process, ensuring adherence to predefined quality standards and production timelines. - Implement and monitor process improv...