Regulatory Affairs Manager/Director (Orange County, CA)

SNAPSHOT!

Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!

Immediate need for a Regulatory Affairs Manager/Director in Orange County, CA who possess:

• Strong foundation in regulatory strategy, documentation, scientific concepts and regulatory frameworks.

• Experience in regulatory submission (IND/ANDA/NDAs) and interaction with FDA and other regulatory agencies.

• Proven ability to coordinate a variety of regulatory documents (quality, preclinical and clinical) in collaboration with other subject matter experts.

• Electronic document management systems literacy and electronic submission experience in eCTD format.

• Experience in regulatory operations, including authoring, formatting, publishing, submitting and archiving through document lifecycle.

• Comprehensive knowledge in regulatory requirements including ICH, FDA, GXPs and other applicable industry standards.

• Computer skills and working knowledge of Microsoft Office (Word, Excel, Powerpoint), Internet Explorer and Adobe Acrobat, etc.

• Results and detailed orientated.

• Basic project management skills.

• Excellent written and oral skills.

• Excellent organizational skills and ability to manage multiple projects and priorities.

• Work well under deadlines.

Key responsibilities include:

• Oversee all regulatory matters related to the Company’s pharmaceutical business in the US and provide guidance in regulatory discussions on ex-US matters.

• Manage regulatory issues related to audits, regulatory agency inspections, product recalls.

• Provide guidance with the development and implementation of clinical trial protocols.

• Prepare and review dossiers and submission packages for regulatory agencies, e.g., IND/ANDA/NDA.

• Prepare and oversee filing of all communications with regulatory authorities.

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable regulations and review processes and documentation on a regular basis.

• Monitor the progress of the regulatory authority review process through appropriate communication.

• Provide regulatory information and guidance for proposed product claims/labeling.

• Assure post-marketing regulatory requirements are met, including pharmacovigilance.

• Liaise with internal functions such as Manufacturing, R&D, and Clinical Operations to obtain necessary information and documents required for regulatory submissions.

• Work with subject matter experts to create and review documents for regulatory submissions or internal processes to ensure regulatory compliance.

• Provide and implement regulatory strategy and plans for a variety of product types with collaboration from all departments.

• Keep abreast of regulatory requirements, including monitoring FDA and other global agencies regulations and standards, and communicate updates internal stakeholders.

• Identify and manage issues that impact submission timelines or regulatory strategy, and communicate progress, including any risks, to Management.

For immediate considerations please email your resume to admin@snapstaffing.com