Regulatory Writing and Submission Scientist

Why Patients Need You ROLE SUMMARY The position is located in the nonclinical toxicology division (i.e., DSRD) of Pfizer; specifically, within the Portfolio and Regulatory Strategy (PRS) group which is responsible for developing and implementing nonclinical toxicology and regulatory strategy for Pfizer’s portfolio. The Regulatory Submissions Scientist...

Why Patients Need You The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated...

Why Patients Need You Seeking a Regulatory writing submission scientist (RWSS) who will liase with Drug Safety Research & Development (DSRD) Regulatory Strategy Leads and Medicine Design/PDM colleagues to prepare and support the expert nonclinical sections (pharmacology/ADME/toxicology) of regulatory dossiers and oversee the integration of all nonclinical...

Key Insurance Regulatory Submission ProfessionalThis role requires a highly organized and detail-oriented individual to ensure all regulatory submissions are uploaded in the portal with concurrence from relevant stakeholders.The ideal candidate will have experience in a similar domain, specifically with regulatory submissions, data maintenance, communication...

**Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...

Job Description Role - Regulatory Affairs - Medical DevicesExperience - 1 to 3 YearsLocation- Madhavaram, ChennaiBudget - As per the industryKey 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...

**Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...

Develop new regulatory policies, processes and SOPs and train key personnel on them - Provide regulatory input to product lifecycle planning - Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes - Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop...

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDAReview of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

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...