Regulatory Affairs Associate - II
333 Lakeside Drive Foster City, CA 94404
Our client is an American biotechnology company that researches, develops and commercializes drugs.
Under supervision of a Regulatory Affairs Manager, the associate will work with cross-functional team members to support regulatory submissions to the US Food and Drug Administration (FDA) for marketed and/or investigational medicinal products for the treatment of HIV-1 infection.
- Prepares regulatory submissions and gathers input from cross-functional team members for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- With guidance from Manager, develops and acquires required regulatory skills and knowledge, including learning about regulatory interactions with health authorities and regulatory strategies to support the development, registration, and maintenance of HIV products.
- Assists with the coordination and tracking of regulatory commitments and submission plans for maintenance activities such as annual reports, periodic safety reports, protocol submissions, and key regulatory filings such as efficacy supplements and labeling supplements.
- Leads the preparation and submission of routine regulatory deliverables including: safety submissions, periodic safety reports, annual reports, investigator submissions, protocol submissions, and others as needed.
- Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
- May contribute to routine local process improvements to support the Regulatory Affairs department.
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
Knowledge and Skills:
- Strong organizational skills and attention to detail, along with the ability to manage a number of projects with tight timelines.
- Excellent verbal and written communication skills and interpersonal skills.
- Able to effectively interface with all levels of management and departments within the company.
- Must have some life science industry experience and a reasonable understanding of regulatory requirements, including US FDA and ICH requirements.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Act as a resource on limited topics within the department.
- Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.
Education and Experience:
- 4+ years of relevant training or industry experience with BS/BA.
- 3+ years relevant training or industry experience with advanced degree.
- Degree/Advanced degree in a scientific field is strongly preferred.