Job Description

Senior Director / Executive Director of Regulatory Affairs

W2 Contract-to-Hire

Salary Range: $343,200 - $364,000 per year

Location: Redwood City, CA - Hybrid or Remote PST

Duties and Responsibilities:

• Work with Regulatory Affairs to assist in building a high-performing global regulatory function.
• Responsible for ensuring all RA deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines.
• Oversee, coordinate, and deliver regulatory submissions and other relevant regulatory documentation.
• Provide regulatory expertise and leadership to cross-functional teams and other groups.
• Serve as the primary RA representative on one or more global projects at any one point in time.
• Analyze data, the regulatory environment, and business objectives to recommend priorities.
• Provide internal teams with direction on regulatory authority interactions.
• Develop regulatory risk management and contingency plans. Communicate plans to management as appropriate.
• Participate as a standing member in various teams, depending on assigned projects and associated programs, coordinating cross-functional contributions.

Requirements and Qualifications:

• Bachelor's Degree required (life sciences disciplines strongly preferred)
• 8 or more years of relevant experience in regulatory affairs or related functions in drug/biologics development
• Broad understanding of international regulations, processes, and issues in drug/biologics development
• Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US and globally
• Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions, and roles involved in the product development process
• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
• Strong interpersonal, verbal communication, and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat
• Excellent attention-to-detail
• Excellent written communication skills
• Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, able to raise problems or challenges productively and maturely.
• Strong negotiation skills: can effectively drive discussions and decisions toward desired results.
• Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy.
• Works well within teams and is effective in collaborating with others internally and externally

Desired Skills and Experience

Clinical Regulatory Affairs, Oncology, drug development, project management, Microsoft Office

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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