
Regulatory Affairs Assistant
2 days ago
Company Overview
Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at
Job Overview
We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.
Qualifications and Skills
- Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
- Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
- Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
- In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
- Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
- Familiarity with GxP standards to assure the quality and integrity of processes and products.
- Experience in quality management systems to oversee processes meeting both internal and external requirements.
- Understanding of labeling requirements to ensure product labels meet regulatory standards.
Roles and Responsibilities
- Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
- Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
- Monitor and track submissions and ensure all regulatory timelines are met.
- Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
- Provide support in the development of regulatory strategies and implementation plans.
- Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
- Prepare and review technical documentation to ensure compliance with regulatory standards.
- Support internal and external audits by gathering necessary documents and evidence.
-
Regulatory Affairs
2 days ago
Hyderabad, Telangana, India Clininfotech Full time ₹ 4,00,000 - ₹ 6,00,000 per yearWe are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...
-
Regulatory Affairs CMC
2 days ago
Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC
-
Regulatory Affairs Associate
21 hours ago
Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval
-
Hyderabad, Telangana, India SREE GURU PRECISION MANUGACTURING SOLUTIONS OPC PVT(SGMPS) Full time ₹ 3,84,000 - ₹ 4,60,800 per yearJob Summary:We are seeking a motivated and detail-oriented Regulatory Affairs Executive with 1–2 years of experience in the medical devices industry. The role involves supporting regulatory submissions, maintaining compliance with local and international regulations, and assisting in the preparation of technical documentation for product approvals and...
-
Regulatory Affairs
2 days ago
Hyderabad, Telangana, India Biological E Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRegulatory Affairs Job OpportunityDesired Experience : 3- 9 yearsJob Location : Genome Valley, Shameerpet, HyderabadPreferred Industry : Vaccines / BiotechDesignation: Senior Executive/ ExecutiveQualification: M. Pharmacy/ M. Sc/ B. PharmacyJob Responsibilities:Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World...
-
Regulatory Affairs _ US Market
2 weeks ago
Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per yearGreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...
-
Regulatory Affairs Specialist Ii
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Collaborate and partner with Design QA R D Sustaining Engineering Clinical Affairs Marketing and...
-
Regulatory Affairs CMC Associate
3 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...
-
Regulatory Affairs Officer
1 week ago
Hyderabad, Telangana, India Weekday AI Full time ₹ 9,00,000 - ₹ 12,00,000 per yearThis role is for one of the Weekday's clientsSalary range: Rs Rs ie INR LPA)Min Experience: 3 yearsLocation: HyderabadJobType: full-timeWe are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and...
-
Regulatory Affairs CMC Associate
3 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...