3208 Regulatory Affairs Jobs - Page 3

Manage regulatory affairs, compliance and operations Ensure ISO 13485:2016 standards; maintain QMS Handle complaints and reviews efficiently Collaborate on RA strategies and submissions Experienced with USFDA (510k), CDSCO, ASEAN regulation

Job Title: Manager - Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G10 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.” Key Responsibilities: Establish and lead the downstream group ...

Job Title: Executive – FRD Non-Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A 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.” Key Responsibilities: Experience in Formulation R&D product...

About The Role Job Title – Insurance + Analyst/Consultant/Manager + S&C Management Level:Analyst/Consultant/Manager Location:Gurugram/Mumbai/Bengaluru Must have skills:Insurance + Generic + Guidewire/Duckcreek + Consulting Good to have skills:Insurance + Generic + Guidewire/Duckcreek + Consulting Experience :5 to 15 years Education qualification :Graduation + Post graduation About The Role Analyst/Consultant/Manager - Insurance Find endless opportunities to solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice:Industry Consulting, GN S&C I Areas of Work:Insurance (core) Explore an Exciting Career at Acce...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: BCom Years of Experience: 1 to 3 years Language - Ability: English(Domestic) - Intermediate 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 d...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members to achieve project goals effecti...

Role & responsibilities • Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971. • Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements. • Lead comprehensive risk analysis and mitigation for Hazard identification Design FMEA (dFMEA) Use FMEA (uFMEA) Product risk analysis and control • Integrate risk controls into the design and development process to ensure safety and compliance. • Collaborate with design, clinical, regulatory, and quality teams to assess and mitigate risks throughout the product lifecycle. • Provide risk-related input during design reviews, change control boards, and techn...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 d...

JD for Executive -Regulatory Affairs Designation: Executive RA Location: Mumbai Must have Key Skills : CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals. Other essential skills: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking Job description: Common requirements: 1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re- registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal/ Variations submission . 4) Must...

Role & responsibilities Support regulatory strategy, registration, and lifecycle management for Pharma products in ROW markets. Prepare, review, and submit regulatory dossiers (CTD/eCTD) as per regional guidelines. Coordinate with regulatory agencies, distributors, and affiliates for approvals and query responses. Maintain regulatory documents, product information, and ensure compliance with health authority requirements. Monitor regulatory updates for ROW markets and share impact with stakeholders. Manage post-approval submissions including variations, renewals, and compliance updates. Work with cross-functional teams (R&D, QA, Supply Chain, Commercial) on regulatory matters Preferred candi...

Role & responsibilities Support regulatory strategy, registration, and lifecycle management for Pharma products in ROW markets. Prepare, review, and submit regulatory dossiers (CTD/eCTD) as per regional guidelines. Coordinate with regulatory agencies, distributors, and affiliates for approvals and query responses. Maintain regulatory documents, product information, and ensure compliance with health authority requirements. Monitor regulatory updates for ROW markets and share impact with stakeholders. Manage post-approval submissions including variations, renewals, and compliance updates. Work with cross-functional teams (R&D, QA, Supply Chain, Commercial) on regulatory matters Preferred candi...

Dear Candidates, We have an opportunity with clinical trial development and CRO related assets and capabilities from an existing ACRO/SMO organization that is based in Chennai. We have over 10 years of experience running clinical trials as part of the global Group. Position Overview The Head of Regulatory Affairs is responsible for providing strategic leadership, oversight, and execution of all regulatory activities within the organization. This role ensures that the CRO maintains compliance with global regulatory standards (FDA, EMA, MHRA, CDSCO, etc.) and supports clients in achieving regulatory milestones efficiently and compliantly. The position requires strong leadership, scientific exp...

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories Private Limited, MSN House, D.No: 2-91/10 & 11, White Fields,Kondapur, Hyderabad on Sunday 16-11-2025 Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 03 to 12 years of experience in FML Regulatory Affairs Job Title : Executive / Senior Executive / Junior Manager / Assistant Manager / Deputy Manager Experience : 03 to 12 years in FML RA field Education: B Pharm \ M Pharm Department : Regulatory Affairs - FML Roles & Responsibilities : Collect documents from various departments to prepare regulatory submissions. Prepare regul...

Prepare, compile, and review dossiers (CTD/eCTD format) for ROW markets covering Modules 3-5 . Support in preparation and submission of Modules 1-2 (Administrative and Summaries) as per regulatory guidelines. Ensure that dossier submissions comply with the respective country-specific regulatory requirements . Coordinate with cross-functional teams R&D, QA, QC, Manufacturing, and Packaging to gather required documents and technical data. Review and ensure correctness and consistency of CMC (Chemistry, Manufacturing & Controls) documentation for injectable products. Support variations, renewals, and post-approval changes for ROW regulatory filings. Maintain up-to-date knowledge of ROW regulato...

Summary: The State Team Lead Statutory will oversee the statutory compliance framework for NRO development across the state. This role demands strong coordination, communication, and relationship management skills to ensure timely approvals, effective collaboration with multiple stakeholders, and strict adherence to regulatory standards supporting network growth. Job Role: State Team Lead Statutory Job Accountabilities1. Statutory Compliance: Oversee and expedite the process of obtaining statutory approvals for NRO cases within the state, ensuring adherence to defined timelines. Maintain close coordination with NDMs/SBDMs, the SCO team, and LOI Holders to secure approvals in a timely manner....

Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...

Experience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or Documentation Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards Experience in DHF assessment and remediation Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements Documentation skills validation reports, change control, deviation records Strong communication skills, both ...

Designation: Senior Export Manager Documentation Location: Ahmedabad / Morbi / Delhi(One employee in each location) Industry: Ceramic Manufacturing Salary: no bar for the right candidate Requirements: 1. Preference: Candidates from the Ceramic Industry/ Has Ceramic Industry knoweldge. 2. Graduate 3. Typing speed: 35–40 WPM 4. Strong experience in export documentation (preferably 5+ years) 5. Good proficiency in emails, Excel, and client follow-ups 6. Should have handled pre-shipment and post-shipment documentation, LC, BL, and bank coordination Role Overview: 1. Lead export operations team. 2. Coordinate with the sales team, clients, shipping lines, and factory team 3. Prepare quotations, pr...

Designation : Asst. Manager/Sr. Executive - Quality Assurance & Regulatory Affairs Qualification: B. Pharma, .B.Sc ( Chemistry), M. Pharma, M.SC ( Chemistry ) Experience: 6-9 Yrs CTC : 70k to 85 K Sex: Male candidate only Location: Dahej Required Candidate profile Candidate must have experience in pharma or api or chemical or food company in Quality assurance department

Update QMS procedures, create documents & update Quality Manual with Regulatory requirements. Product submission-Domestic & International, Registration Renewal, Dossier Prepare for Regulatory agencies Required Candidate profile B. Tech/B. Pharma/B. Sc. with 3-5 yrs exp. in Regulatory Affairs / Quality Assurance. Knowledge of QMS & Regulations e.g. ISO 13485, ISO 9001, 21 CFR 820, MDR 745. Compile Technical Files / QA Records

SIAM and external agencies on upcoming Safety Regulations discussions. Has Awareness on Global Regulations and standards on Safety, in-line with International Standards. Participation in Automotive Industry Standards(AIS) & BIS Committees .

Key Responsibilities: 1. Product Registration & Approvals: Independently manage the full lifecycle of product dossiers and lead registration, renewals, and post-approval updates. Identify, analyse, and communicate relevant domestic and international regulations impacting product registration for all assigned markets, ensuring the team is informed of regulatory changes affecting submission strategies. Lead the preparation and coordination of regulatory submissions for each product launch, ensuring all requirements and deadlines are met for timely approvals. Oversee approval timelines, identify possible delays, and implement corrective actions to meet deadlines. 2. Team Leadership & Cross-Func...

DOSSIER PREPARATION, ACTD, CTD, ROW, ASEAN, DOCUMENTS REVIEW, MAINTAIN DATABASE

SPS Canada Immigration is looking for Education Advisor 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