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Regulatory Affairs Manager

Company: Unicon Pharma
Location: San Jose
Posted on: October 17, 2020

Job Description:

Location: Foster City, CA 94404 OR Remote Duration: 06 Months-Contract. Note: Open to remote working candidates! Must have experience with small molecules and biologics Development pathway - Strong scientific environment-Supports the liver transplant team and their global strategy. 12 people on the Liver franchise team mostly supporting approved product for Hep A and B. Over 5 years of experience. Supports the Global Clinical and non-clinical franchise Need for US Regulatory and Global strategy experience Collaborates with cross-functional teams. There will be an initial phone screen, then a face to face or Skype 1. US Regulatory knowledge - major market request to be processed. 4 year bachelor degree minimum required. Job Description: The client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative to improve the care of patients living with life-threatening diseases around the world. Clients therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Essential Duties and Job Functions: Work collaboratively with global and regional regulatory product leads in supporting global clinical and nonclinical regulatory strategy development, planning, and implementation for multiple complex programs across the liver franchise Provide regulatory guidance and critically review documents to ensure alignment of rest of world submissions and response to Health Authority questions are aligned with major market strategies and product Company Core Data Sheets Contributes to the development and regulatory review of documents required for maintenance of products in assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include aggregate safety reports (e.g. PSUR, DSUR, etc), clinical protocols, clinical study reports, investigator brochures, Module 2 documents, regional labeling documents and other product-related documents Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements Responsible for preparing and reviewing moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include safety reports, protocol and information amendments, new investigator amendments, responses to health authority requests for information, labeling supplements and NDA annual reports Responsible for preparing and submitting moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include safety reports, protocol and information amendments, new investigator amendments, responses to health authority requests for information, labeling supplements and NDA annual reports May serve as primary contact with local Regulatory Authority responsible for ensuring IND and NDA applications are updated and maintained in accordance with FDA requirements May serve as Regulatory representative on Regulatory Project Team, Regulatory Submission Teams, study management teams, clinical teams and other subteams Participates in group meetings and local and global product submission team meetings and presents project status updates and strategy approaches to moderately complex programs/projects May provide regulatory expertise to submission teams on specified projects and topics Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments Knowledge and Skills: Knowledge and understanding of US regulations and guidelines for small molecule and biologic product development and maintenance Ability to apply major market strategies to review and development of regional responses to Health Authority requests for information Previous experience in the preparation and submission of clinical/non-clinical regulatory documents in support of US IND and NDA Experience with marketed products is a plus Excellent organizational, computer and documentation skills and an ability to prioritize effectively with tight timelines Strong interpersonal skills including verbal and written communication

Keywords: Unicon Pharma, San Jose , Regulatory Affairs Manager, Executive , San Jose, California

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