Associate Director, Regulatory Affairs
W2 Contract
Location: Redwood City, CA - Remote Role
Job Summary:
As an Associate Director of Regulatory Affairs, you will represent regulatory affairs on cross-functional teams and provide regulatory advice on clinical development matters. The ideal candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making, and provide effective leadership to ensure successful regulatory outcomes.
Duties and Responsibilities:
- Develop, implement, and maintain initiatives, processes, and procedures with recognition of when to consult departmental seniors concerning risks.
- Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
- Utilize a comprehensive knowledge of regulations, regulatory authority guidance, and industry practices to support organizational objectives.
- Proactively identify risks and devise mitigation strategies.
- Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
- Perform regulatory research to inform business strategy. Assess and communicate risks.
- Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Requirements and Qualifications:
- Bachelor's Degree in a relevant field, an advanced degree is preferred.
- 7+ years in the pharmaceutical/biotech industry or relevant work experience and at least 5 years in Regulatory Affairs.
- Experience in preparing and submitting extensive and complex regulatory documentation to support health agency review/approval procedures and post-approval activities.
- Experienced in representing Regulatory Affairs on cross-functional teams and presenting to senior management. Excellent communication skills.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
- Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions is preferred.
- Direct experience with oncology drug development is highly preferred.
- Experience with combination studies, multiple expansion cohorts, and basket or umbrella master protocols is highly preferred.
- Direct experience with FDA-expedited programs is highly preferred.
Desired Skills and Experience
Regulatory Affairs, regulatory submissions, drug development, oncology, FDA, EMA
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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