Regulatory Affairs Associate
California All, CA 94404 US
R&D Partners is seeking to hire a Regulatory Affairs Associate III in Foster City, CA.
Benefits of this role:
Benefits + 401k
Your main responsibilities as a Regulatory Affairs Associate III:
Responsible for the preparation of moderately complex regulatory submissions which require interaction
with departments outside of Regulatory Affairs CMC for investigational products for US, Asia and LATAM and marketed products for US in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensure ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Develop and maintain knowledge of regulatory requirements independently and with line manager.
Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.
What we are looking for in a Regulatory Affairs Associate III:
A Bachelor s Degree with a minimum of 6+ years of relevant training or industry experience preferably in a
GMP environment, OR a Master s Degree with a minimum of 4+ years of relevant training or industry experience preferably in a GMP environment.
Degree in a relevant scientific field.
Relevant Regulatory CMC submission experience.
Regulatory Affairs Certification (RAC).
Why Choose R&D Partners?
Refer a Friend bonus
$30.93 - $38.66 (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.