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Form of work- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description:
- Regulatory Affairs - working in close collaboration with Oncology Global Regulatory Strategists and the publishing team to ensure timely submissions to the FDA.
Position Summary
- Perform independently, or with only minimal supervision, regulatory, technical, or administrative tasks to support the ongoing operations of the Regulatory Affairs Department. Coordinate and oversee the preparation of regulatory sections/components that are included in domestic and international submissions to ensure that they are prepared correctly, properly reviewed, and submitted with the correct forms to the appropriate division within FDA or other regulatory authority. Perform quality control checks on these submission components, as well as on corrections made to these components, and ensure compliance with Bayer Standard Operating Procedures (SOPs) and regulations.
Position Duties & Responsibilities
Plans and coordinates all aspects of electronic and paper submissions that are submitted to health authorities. Diversity of submission types and complexity may include all potential dossier types worldwide across all phases of a product lifecycle including INDs, NDA/sNDAs, MAAs, CTD/eCTDs, CTA/IMPDs, PSURs, Agency Meeting Briefing Packages, Major Variations, Product Renewals, CMC amendments, IND/NDA annual reports, information amendments, DMF updates, etc.
Uses technical computer know-how and experience to work independently on daily projects and apply problem-solving skills to day to day problems with software functionality with minimal supervision.
Researches and provide information electronically and/or in paper to answer critical authority inquiries and/or Bayer internal requests
Prepare forms and cover letters for health authority submissions. Upload final submission documents into document management systems according to eCTD guidelines and maintain regulatory milestones in databases
Support eCTD formatting and quality checks of regulatory documents such as briefing documents and provide submission templates
Liaise with subject matter experts, publishing, and global regulatory strategists to ensure timely submissions to health authorities
Requirements/Preferences
HS diploma
Skill & Competency Requirements:
4+ years of progressively increasing administrative experience
2+ years of experience in the pharmaceutical industry
Knowledge and understanding of regulatory submission requirements, eCTD format, and other related material is essential.
Must be fully cognizant of and responsive to shifting priorities and be able to interact with professional staff.
Excellent organizational and verbal/written communication skills are necessary. Independent judgment, discretion and problem solving is required.
Excellent computer skills and professional demeanor required for interactions with international colleagues and health authority representatives, including a working knowledge of database management as well as proficiency in Microsoft Word, Excel and PowerPoint.
Preferences:
Experience with document management systems
All your information will be kept confidential according to EEO guidelines.
