Associate Regulatory Affairs - Chennai

We are looking for a highly skilled and experienced Regulatory Affairs (Publishing) Associate to join our team in the Pharmaceutical and Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs, publishing, and healthcare. · Roles and Respon ...

Dossier preparation, compilation, submission & post-approval (ACTD/CTD formats) · Handle complete regulatory activities for ROW & LATAM markets · 3.Review technical documents, DMF, stability data, & artwork · Product registrations, renewals · Required Candidate profile · B. ...

Prepare, review, and submit amendments and supplements for the assigned products. · Prepare summary documents for regulatory submission. · Prepare, review, and submit responses to the Agency s queries for the assigned products. · Compile and submit Global Annual Reports. · Review ...

The person will be responsible for the compilation/review of supplements (including Injectable and OSD dosage form), Global Annual Reports, and preparation of summary documents for regulatory submission. · Prepare, review, and submit amendments and supplements for the assigned pr ...

Regulatory Affairs Specialist. Author, revise and maintain safety data sheets (SDSs) in compliance with regulations. · ...

Looking for candidate with knowledge of FSSAI nutraceutical regulations labeling packaging guidelines License documentation Provide writeups NPD & ingredient research. Good communication skills required. · ...

Developing & executing regional RA strategies, including submission planning, regulatory intelligence, risk assessments. Leading product dossier preparation & submission of drug products across markets; prepare and submit CTD/eCTD/ACTD. · Required Candidate profile · Exposure o ...

ClinChoice is a partner to the largest pharmaceutical innovators in the world. · Support preparation of eCTD submissions. · ...

Role & responsibilities · Regulatory Submissions & Documentation · Prepare, compile, and submit regulatory dossiers for APIs · Support preparation and maintenance of CTD / eCTD modules · Handle product registration, renewal, and variation submissions · Compliance & Regulatory Coo ...

Fusion De Nova is a fast-growing merchant exporter of high-quality pharmaceutical products from India, serving diverse international markets across Africa and Latin America — including the Dominican Republic, Honduras, Guatemala, and El Salvador. As we expand our global footprint ...

ClinChoice is a partner to pharmaceutical innovators in clinical operations. This role supports eCTD submissions. · Support preparation of eCTD submissions · Perform document formatting and hyperlinking · ...

We are looking for a highly skilled and experienced Regulatory Affairs Manager to lead our regulatory affairs team in the Pharmaceutical and Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs, with expertise in regulated markets. · Rol ...

This is a full-time hybrid role for a Regulatory Affairs Associate focusing on medical devices- QMS & EU MDR compliance. · Experience with Quality & Regulatory Documentation in compliance with ISO 13485 & EU MDR/ IVDR and expertise in preparing accurate regulatory records · Profi ...

We are seeking a Regulatory Affairs Associate to focus on medical devices QMS & EU MDR compliance. · This is a full-time hybrid role with opportunities for partial work-from-home flexibility based in Chennai.The successful candidate will prepare review and submit regulatory docum ...

We are seeking an experienced Regulatory Affairs Specialist to support U.S. and global regulatory activities for a growing biotech organization. · We are looking for someone with strong project management skills who can manage submission timelines and cross-functional coordinatio ...

We are seeking a Regulatory Affairs Executive to join our Quality Department. The ideal candidate will be responsible for regulatory compliance documentation quality management system implementation and ensuring adherence to international and Indian medical device regulations. · ...

+This is a role for an experienced Regulatory Affairs professional to lead the development and implementation of regulatory strategies for product registration across European markets. · +Develop and implement regulatory strategies for product registration across European markets ...

We are looking for RA Specialist - Formulation Injectable for a leading pharma company at Chennai. · Greetings · , We are looking for RA Specialist - Formulation Injectable for a leading pharma company at Chennai.Preparation & review of regulatory documents. · ...

We are looking for an experienced Regulatory Affairs Specialist with strong exposure to medical device or IVD manufacturers in India who export their products to advanced regulated markets such as USA (FDA), Europe (EU MDR/IVDR), Japan (PMDA), Australia (TGA), India Regulatory an ...

We are Hiring for QMS Engineer Medical Devices - ISO 13485 FDA QSR & EU MDR , ISO 14971 and ISO 9001 for our Medical Devices MNC Industry in Chennai Oragadam · Key Responsibilities: · 1. QMS Implementation & Maintenance · Develop, implement, and maintain the Quality Management S ...