3208 Regulatory Affairs Jobs - Page 27

Overview This role will assist the Specifications Management teams located in Mexico Business Services (MBS) or Hyderabad Business Services (HBS) to ensure exceptional service is provided in support of R&D Spec Management globally. This role will apply technical expertise and coordinate with in-market and GBS employees, as well as external resources when required, to develop clear and concise Formula, Ingredient and/or Packaging specifications, maintain existing specs and supplier relationships, and manage tracking and uploading into relevant systems. Depending on team structure, may include the opportunity to guide, mentor, check the work coming from a Spec Writer Analyst. Responsibilities ...

Role Overview: The Technical Director Energy will provide strategic leadership, technical expertise, and business development support to drive the growth and delivery of projects within the Energy sub-business line under the Environment, Water, and Energy (EWE) business. The role requires strong technical capabilities, a deep understanding of the energy sector, and the ability to engage with clients, stakeholders, and multidisciplinary teams to ensure the successful execution of projects Key Responsibilities: Technical Leadership: Provide thought leadership and strategic direction for energy-related projects, including renewable energy, power systems, grid modernization, energy transition, a...

Hello Engineer, We are looking for Project Leader to work onsite with a Global Heavy Engineering MNC Epiroc Mining (Design Center of Atlas Copco) at Bangalore . Qualifications & Experience: B.E./B.Tech in Mechanical Engineering. 5 to 7 years of experience in regulatory affairs, trade compliance, or product certification. Strong understanding of BIS certification processes, QCOs, and related standards . Key Responsibilities: Lead and support projects to secure BIS licenses for imported and locally manufactured products. Coordinate with internal teams, suppliers, and consultants to ensure smooth certification processes. Ensure full compliance with BIS standards, QCOs, and regulatory requiremen...

Velji Ratna Sorathia Infra Private Limited. is looking for Manager QC to join our dynamic team and embark on a rewarding career journey. We are seeking a highly skilled and motivated Manager of Quality Control to oversee all aspects of quality control activities within our organization. The successful candidate will be responsible for ensuring that products meet quality standards and regulatory requirements by developing and implementing robust quality control processes and procedures. The Manager of QC will lead a team of quality control technicians and analysts, manage day - to - day QC operations, and collaborate with cross - functional teams to drive continuous improvement initiatives. T...

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...

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...

We are looking for a seasoned Corporate Affairs leader with strong state-level influence and policy advocacy experience. What Youll Do - Build strong engagement with ministries, regulators, and secretariats Lead policy advocacy and represent the company at apex forums (FICCI, CII, ASSOCHAM, etc.) Anticipate and shape regulatory developments impacting business operations Drive licensing, statutory approvals, and compliance at the state level Partner with CXOs and senior leadership for external stakeholder strategy Who Were Looking For - 18+ years in corporate affairs, policy advocacy, or government relations Strong state-level network with bureaucrats, regulators, and political leaders Track ...

Assists clients in the selection, implementation, and support of SAP EHS. Lead multiple sized projects as team member or lead to implement new functionalities and improve existing functionalities including articulating, analysing requirements and translating them into effective solutions Prepare and conduct Unit Testing and User Acceptance Testing Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 7+ Years of experience in SAP PLM (Product Lifecycle Management ) & PLM EHS with end to end implementation and support. Well conversant in working on Incident, Problem, Change and Release Management. Ability to articulate and clear...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Roles and Responsibilities: The individual will be responsible for overseeing end-to-end compliance for both Indirect and Direct Taxes for multiple countries. This role will be reported directly to the Tax Operations Delivery Manager. Seeking a detail-oriented and proactive Tax Operations Specialist/Sr. Specialist to support the accurate and timely execution of tax-related processes across our organization. This role involves managing tax documentation, ensuring compliance with regulatory requirements, supporting tax reporting, and collaborating with internal and external stakeholders to streamline operations. Tax Documentation & Compliance Maintain and validate tax documentation Ensure comp...

We are looking for a Senior STEM Content Analyst with strong expertise in CMC Biologics to join our Life Sciences team in India. The ideal candidate will have a solid background in pharmaceutical development or regulatory affairs, particularly in biologics and biopharmaceuticals, and will be passionate about delivering high-quality content that supports global health authority submissions. You will be responsible for monitoring regulatory changes, authoring detailed CMC reports, and supporting both internal teams and external customers. Your ability to work collaboratively across global teams, manage complex regulatory data, and contribute to product innovation will be key to your success in...

Job Title: Senior Executive/Executive – MSTG Non-Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A/G11B Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” JOB DESCRIPTION Process Development ...

Quality Control Leadership Raw Material to Finished Product Quality Documentation & Regulatory Compliance Audit & Inspection Readiness Laboratory Operations Product Lifecycle & Continuous Improvement Customer Interface & Regulatory Documentation

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

About Us : Sydler Group of Companies is a leading manufacturer and exporter of excellent quality and reliable Pharmaceutical Formulations, Herbal formulations, Nutraceuticals & Dietary Supplements, and Nutritional food products, catering to discerning market needs globally. Ever since its inception in 2004, we have set new benchmarks in the arena of herbal products manufacturing, leveraging state-of-the-art infrastructure, skilled professionals, and uncompromised commitment towards quality and innovation. Role : Sr. Executive RA/ Executive RA Responsibilities : To Coordinate with relevant department for arranging documents - To prepare / compile dossier for allocated products / countries - T...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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 worlds leading biopharma companies bring their vision to life enabling them to i...