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DOCS Regulatory Affairs Manager in Helena, Montana

Regulatory Affairs Manager

Ref #: 21173

Employment type: Permanent - Full-Time

Location: Remote/Home-based

Posted: 25-Mar-2020


Essential Duties and Job Functions:

• 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

• 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, US labeling documents and other product-related documents

• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements

• 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.

• 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 are essential in this collaborative work environment

• Ability to work in a cross-functional team environment and project teams

• Strong attention to detail and the ability to handle multiple tasks

• Demonstrates capability to act as primary Company contact with Regulatory Authorities

• Work is performed under minimal direction of a senior Regulatory Affairs professional

Education and Experience

• 5+ years of experience in Regulatory Affairs or other relevant industry experience

• Degree in a scientific field is preferred

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.