Job Description

Senior Associate, Regulatory Affairs

W2 Contract-to-Hire

Salary Range: $124,800 - $145,600 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will 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, as well as 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 the development and implementation of 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 assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
• Work with the manager on the acquisition and development of required regulatory skills and knowledge.

Requirements and Qualifications:

• Bachelor's degree in a relevant field.
• Two or more years of prior experience in a Regulatory Affairs department at a drug or biologics company.
• Some familiarity with regulatory requirements for the development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
• Willing to advance my knowledge of regulatory practice through classes, certifications, and webinars.
• Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.

Preferred Qualifications:

• Experience in oncology drug development.
• Experience with supporting the preparation and submission of large, complex regulatory submissions, including NDAs.
• Excellent written and verbal communication skills.

Desired Skills and Experience

Regulatory Affairs, FDA regulations, ICH guidelines, regulatory submissions, NDAs, drug development, biologics, oncology, regulatory strategy, health authorities, compliance, electronic document management systems, project management, cross-functional collaboration, regulatory documentation, submission planning, regulatory requirements, SOPs, timeline management, MS Office, Adobe Acrobat, written communication, verbal communication, regulatory guidelines, pharmaceutical regulations, clinical development, regulatory approval process, stakeholder management, regulatory tracking systems, quality assurance, regulatory compliance, drug approval, biological products

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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