Sr. Associate - Regulatory Affairs CMC
Hays

Foster City, California

This job has expired.


The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Bio - Pharmaceutical Company is seeking a Sr. Associate - Regulatory Affairs CMC in Foster City, CA.

Role Description

Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational products 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 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. Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments. Work cross-functionally within a matrixed organization. Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines. Must be capable of leading a small team in preparation of regional submissions. Must work well under deadlines and have excellent attention to detail. Strong computer and organizational skills required. Work is performed under limited direction of a senior Regulatory Affairs professional. Excellent verbal and written communication skills and interpersonal skills are required.

Skills & Requirements

  • A Bachelor's Degree with a minimum of 5+ years of relevant training or industry experience in Biologics, preferably in a GMP environment.
  • A Master's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment.
  • Preferred Degree in a relevant scientific field.
  • Relevant Regulatory CMC submission experience.
  • Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements.
  • Regulatory Affairs Certification (RAC) is a plus but not required.
Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information. #1149288


This job has expired.

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