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Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a
Regulatory Affairs Associate - II Job Description: Job Title: Regulatory Affairs Associate - IIJob Type: ContractJob Location: Foster City, CaliforniaWork Schedule: On-site Responsibilities:- 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.
- A Bachelor’s Degree with a minimum of 5+ years of relevant training or industry experience in Biologics, preferably in a GMP environment.
- OR 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.
- ID: #49848740
- State: California Fostercity 00000 Fostercity USA
- City: Fostercity
- Salary: $0 - $0
- Job type: Contract
- Showed: 2023-05-03
- Deadline: 2023-06-19
- Category: Et cetera