Regulatory Affairs | Berkeley, CA | Full Time
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib) was the first oral targeted therapy to be approved for the treatment of both metastatic and unresectable melanomas. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and patients.
Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 70 employees based in Berkeley, California and this position will be a critical member of the Regulatory Affairs team reportingdirectly to the Associate Director of Regulatory Affairs. The primary responsibilities for this position will be to support creation, editing, and compilation of clinical, nonclinical, and regulatory documents for INDs, amendments, annual reports, safety updates, and agency correspondence. This position will also be responsible for providing support with managing submissions to Health Authorities.
Responsibilities include but are not limited to:
- Support day-to-day regulatory functions including planning, compilation, and management of regulatory submissions including amendments, annual reports, new protocol, protocol amendments, safety reports, agency correspondence, etc.
- Oversee electronic submissions and communication with eCTD publishing vendor
- Ensures high quality submission elements in eCTD format in compliance with all applicable regulations and guidance documents
- Edit, format, and assemble submission documents in accordance with established timelines
- Works closely with subject matter experts (e.g., clinical, clinical operations, CMC/manufacturing, and preclinical) to support authoring and formatting of submission documents
- Maintain the archives for regulatory authority communications, commitments, and submissions
- Understanding of SOP hierarchy and revision control. Assists in the maintenance of SOP’s to assure accurate and up-to-date information is filed and available to appropriate personnel.
- Demonstrate continuous effort to improve operations, decrease turnaround times, streamline work processes, and work cooperatively
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree in related field required (or relevant experience)
- 1-2 years of experience in regulatory affairs/operations role in the pharmaceutical/biotechnology industry
- Understanding of the drug development process
- Must be knowledgeable of current FDA regulatory requirements per 21 CFR, including GMP, GCP, and GLP
- Proficiency in eCTD format and FDA submission requirements
- Familiar with eCTD publishing software
- Must be capable of proofreading detailed scientific documents
- Experience using MS Word, Adobe Acrobat Pro, and other MS Office applications
- Experience in regulatory document processing and management preferred
- Strong attention to detail and accuracy
- Highly organized, efficient and self-motivated
- Comfortable in a fast-paced small company environment with minimal direction and adjust workload based upon changing priorities
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment in communicating data
- Desire to learn and tackle new challenges is imperative
Plexxikon, an equal opportunity employer, is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment and provide excellent benefits including health insurance, an annual performance bonus and long-term incentive program, generous time off and much more. To learn more about Plexxikon, please visit our website at www.plexxikon.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Please no phone calls, agencies or recruiters