Associate Director, Regulatory Affairs
- Posted: over a month ago
The Assoc. Director of Regulatory Affairs is responsible for the management of the company regulatory submissions. The position participates in creating strategy, authoring and publishing submission for regulatory authorities. This position is ultimately responsible for the archiving of regulatory communications and submission in a manner that makes appropriate information available to specific DURECT employees for informational purposes.
DURECT Headquarters is based in Cupertino, California.Main Duties & Responsibilities:
- Preparation of regulatory submissions for Ex US and US registration, including IND’s, IDE’s, 510K’s, PMA’s and NDA’s and equivalent documents for Ex US.
- Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
- Assess proposed regulations and communicate new requirements to the organization.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, etc.).
- Participate on project teams and assist/provide regulatory guidance to the project teams and in cooperation with the teams, assist in the design of regulatory strategy for the organization’s product candidates, including the manufacturing, preclinical and clinical aspects.
- Assist VP to recommend appropriate submission structure, identify potential submission problem areas, coordinate, review, assemble and submit all new filings as well as annual reports and amendments.
- Review labeling, manufacturing, clinical documents and clinical sites for regulatory compliance.
- Maintain regulatory databases of submissions and correspondence.
- Create and maintain SOP’s as they pertain to Regulatory Affairs.
- Provide operational expertise in the retention and archiving of specific essential documents per relevant health authority requirements (e.g., FDA, EMEA), by the principles of GCP. These documents include externally-sourced documents from Clinical Investigators, IRB/Ethics Committee and internally sourced documents (e.g., Clinical Protocol, IB, CSR).
- Coordinate the distribution, retrieval, review, approval and archive of clinical and regulatory documents, including TMFs.
- Perform with minimal supervision department related activities, including authoring, review, processing/publishing and archiving of health authority submissions and regulatory intelligence investigations.
- Perform QA/QC audit of documents and submissions. Review documents/submissions for conformance to ICH guidance and other regulatory directives.
- As requested, assist other departments, including Clinical Development/Operations, QA and Document Control, Writing and Publishing.
- BS/MS or BA degree in a scientific or health care discipline or practical hands-on knowledge of the health care industry.
- Minimum of 5 years of industry experience with working knowledge of regulatory or clinical research roles.
- General knowledge of GCP, ICH and FDA regulations, drug development process, regulatory affairs, project management and clinical research procedures is preferred.
- High level of attention to detail
- Excellent organizational skills.
- Strong verbal and written communication skills.
- Proficient computer skills & working knowledge of Microsoft Word, Excel, PowerPoint and MS Access as well as e-mail applications.
- Ability to work independently, prioritize, and actively seek input within a matrix team environment.
- Self-motivated and able to handle multiple tasks.
- Ability to use of both hands for extended periods of time while performing regular tasks
- Ability to lift, move and handle materials weighing up to 25 lbs unassisted
- Limited domestic or international travel may be required
Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
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