What are the responsibilities and job description for the Senior Associate, Regulatory Affairs position at Bayside Solutions?
Senior Associate, Regulatory Affairs
W2 Contract
Salary Range : $83,200 - $104,000 per year
Location : Redwood City, CA - Hybrid Role
Job Summary :
As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect of the department and support interactions with global regulatory authorities.
Duties and Responsibilities :
- Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
- Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
- Prepare and manage routine submissions and related activities. Define and manage detailed timelines to ensure timely delivery of high-quality, compliant, accurate, and complete regulatory submissions.
- Assist in developing and implementing SOPs and systems to track and manage product-associated events.
- Investigate and evaluate regulatory history / background of class, disease / therapeutic / diagnostic context to assist in assessing regulatory implications for development and approval. Assist in developing regulatory strategy and update strategy based upon regulatory changes.
- Stay current on regulatory environment changes and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
- Work with management on the acquisition and development of required regulatory skills and knowledge.
Requirements and Qualifications :
Desired Skills and Experience
Regulatory Affairs, ICH guidelines, FDA, SOPs, drug development, oncology, regulatory submissions, Windows, Outlook, Word, Excel, Acrobat
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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Salary : $83,200 - $104,000
