Regulatory Affairs

Role - Regulatory Affairs - Medical Devices Experience - 1 to 3 Years Location- Madhavaram Chennai Budget - As per the industry Key Responsibilities 1 Regulatory Submissions Prepare and submit regulatory documents to authorities for approval such as new product applications amendments and supplements 2 Compliance Ensure products meet...

Regulatory Affairs SpecialistThis is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.Key Responsibilities:Amendment and Supplement Preparation: Prepare,...

Regulatory Affairs Specialist Job OpportunityThe ideal candidate for this position will have a strong background in regulatory affairs, with a focus on CMC and USFDA submissions.A key responsibility of the role is leading and managing CMC regulatory activities, including preparing and reviewing technical documents such as Module 2 & 3 (CTD format).Key...

Job Description: Regulatory Affairs Executive (ROW Markets)Industry: PharmaceuticalsExperience: 3-5 YearsLoaction: ChennaiKey Responsibilities:Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.Document Review: Review BMR,...

Regulatory Submission Expert Job Description: As a Regulatory Affairs professional, you will play a crucial role in ensuring the successful submission of regulatory documents for pharmaceutical products. This includes preparing and reviewing new ANDA filings, amendments, and Annual reports to the ANDA. Key Responsibilities: 1. Prepare and review regulatory...

Position: Manager – Corporate Affairs & CommunicationLocation: Oragadam, Chennai , India​ Key Responsibilities:Government Liaison: Serve as the primary point of contact between Vikram Solar and governmental bodies, ensuring effective communication and fostering strong relationships with local and state authorities in Tamil Nadu, and other states and...

Job Description- 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 stability protocols and reports, analytical method validation...

Key Responsibilities:Prepare regulatory submissions and evaluate post-approval changes in compliance with global regulations.Contribute to Lifecycle Management activities by compiling and reviewing technical dossier modules.Compile initial dossiers for various countries, including US, EU, SA, WHO, ANZ, and others.Provide regulatory strategies and conduct...

DescriptionRegulator ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout UsBuckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting...

Job DescriptionDescriptionRegulator ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout UsBuckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and...