Grifols has a Regulatory Affairs Senior Specialist opening in our Los Angeles, California
Grifols has been a leader in the healthcare industry since 1940 by creating innovative
products and services based on the values of ethics, quality and responsibility.
Grifols' activities focus on fulfilling the needs of its patients as well as healthcare
professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than
60 years, Grifols has developed, manufactured and marketed products designed to improve human
health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical
products of proven efficacy, quality and safety.
Duties to be performed:
In the role of Regulatory Affairs Senior Specialist you will coordinate and prepare dossiers
for submission to Canadian, US and worldwide regulatory agencies. You will identify and obtain
documentation for submissions, viz. BLA, IND, annual reports, CBE, CBE-30 supplements, and
Other duties include:
„X Maintain global registration/renewal of licenses worldwide
„X Review submission packages, labeling, SOPs to assure accuracy in documentation
„X Research regulations and guidelines to provide effective regulatory assessment of proposed
„X Assist in training and guiding of new personnel
„X Evaluate, implement and maintain electronic documentation and archiving systems, database
management systems for regulatory dossiers with the goal of submitting labeling and dossiers
in an electronic format, templates for formatting dossiers e.g. Common Technical Document
„X Interact effectively with project teams to obtain information, multi-task and complete
projects in a timely manner
„X Establish and control the label development process
„X Prepare adverse events and safety reports for submissions to the FDA
Minimum 5 years of experience in Regulatory Affairs, working in a plasma-derived Biologicals,
Biopharmaceutical, device or diagnostics industry.
Detail oriented and excellent proof-reading skills
Computer skills (Microsoft Office including Word, Excel, and Access).
BS in a Science-related field, preferably Biology or Chemistry
Contact: Julian Woolley