SciPro Inc.
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Recruitment Consultant specializing in Regulatory Affairs, Validation, and Engineering
Role:
Director Regulatory Affairs Contract:
Initial 6-month (likely to extend OR convert after 12 months) The Opportunity: The Director of Regulatory Affairs will be responsible for leading regulatory strategy across designated oncology programs. This individual will work closely with drug development teams to deliver pragmatic, actionable, and well-vetted regulatory guidance that supports program goals and milestones. In addition, the Director will play a key role in shaping internal regulatory processes and cross-functional alignment, ensuring a consistent and forward-thinking approach to regulatory strategy. Responsibilities: Serve as the Regulatory Study Lead, providing clear, effective regulatory strategy for global oncology programs. Mentor, motivate, and develop direct reports to drive performance and professional growth. Anticipate regulatory needs for late-stage oncology programs and ensure adequate resources to meet critical milestones. Build and execute global regulatory strategies that integrate competitive insights, expert input, and corporate objectives. Promote consistency in regulatory approaches by applying lessons learned across multiple programs. Partner closely with leaders in Clinical Research, Clinical Operations, Medical Writing, Quality, and other functions to ensure cross-functional alignment and team success. Required Skills, Experience, and Education: Degree in life sciences, pharmacy, medicine, or a related field, with at least 12 years of experience in the pharmaceutical/biotech industry, including a minimum of 8 years in Regulatory Affairs with direct strategy and leadership responsibilities. Proven track record in developing and executing global regulatory strategies and submissions. Demonstrated success leading health authority interactions and negotiations. Significant experience in oncology drug development, including oversight of large, global Phase 3 trials and platform studies. Experience in alliance management and collaboration with external partners in development or commercialization. Strong ability to represent Regulatory on cross-functional teams and to present effectively to senior leadership. Excellent communication, planning, and organizational skills, with the ability to manage multiple priorities under tight timelines. Preferred Skills: Experience with dose optimization in oncology. Prior NDA submission experience strongly preferred. Seniority level
Seniority level
Director Employment type
Employment type
Contract Job function
Industries
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Role:
Director Regulatory Affairs Contract:
Initial 6-month (likely to extend OR convert after 12 months) The Opportunity: The Director of Regulatory Affairs will be responsible for leading regulatory strategy across designated oncology programs. This individual will work closely with drug development teams to deliver pragmatic, actionable, and well-vetted regulatory guidance that supports program goals and milestones. In addition, the Director will play a key role in shaping internal regulatory processes and cross-functional alignment, ensuring a consistent and forward-thinking approach to regulatory strategy. Responsibilities: Serve as the Regulatory Study Lead, providing clear, effective regulatory strategy for global oncology programs. Mentor, motivate, and develop direct reports to drive performance and professional growth. Anticipate regulatory needs for late-stage oncology programs and ensure adequate resources to meet critical milestones. Build and execute global regulatory strategies that integrate competitive insights, expert input, and corporate objectives. Promote consistency in regulatory approaches by applying lessons learned across multiple programs. Partner closely with leaders in Clinical Research, Clinical Operations, Medical Writing, Quality, and other functions to ensure cross-functional alignment and team success. Required Skills, Experience, and Education: Degree in life sciences, pharmacy, medicine, or a related field, with at least 12 years of experience in the pharmaceutical/biotech industry, including a minimum of 8 years in Regulatory Affairs with direct strategy and leadership responsibilities. Proven track record in developing and executing global regulatory strategies and submissions. Demonstrated success leading health authority interactions and negotiations. Significant experience in oncology drug development, including oversight of large, global Phase 3 trials and platform studies. Experience in alliance management and collaboration with external partners in development or commercialization. Strong ability to represent Regulatory on cross-functional teams and to present effectively to senior leadership. Excellent communication, planning, and organizational skills, with the ability to manage multiple priorities under tight timelines. Preferred Skills: Experience with dose optimization in oncology. Prior NDA submission experience strongly preferred. Seniority level
Seniority level
Director Employment type
Employment type
Contract Job function
Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at SciPro by 2x Get notified about new Director of Regulatory Affairs jobs in
Palo Alto, CA . Director/Senior Director, Regulatory Affairs Strategy
Menlo Park, CA $205,000.00-$275,000.00 3 weeks ago Vice President / Head of Regulatory Affairs
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Foster City, CA $165,495.00-$235,620.00 2 days ago Director, Regulatory Affairs - Job ID: 1702
Palo Alto, CA $225,000.00-$240,000.00 2 weeks ago Associate Director Regulatory Affairs - Global Regulatory Services
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Foster City, CA $270,000.00-$285,000.00 1 week ago San Francisco Bay Area $191,250.00-$272,250.00 2 weeks ago Foster City, CA $210,000.00-$225,000.00 2 weeks ago Associate Director/Director Regulatory Affairs
South San Francisco, CA $196,000.00-$240,000.00 2 weeks ago Associate Director, Regulatory Affairs - Global Labeling
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San Francisco Bay Area $190,000.00-$240,000.00 18 hours ago Exec Director, Regulatory Affairs-Combination Products & Devices
San Francisco Bay Area $274,550.00-$390,830.00 2 weeks ago San Mateo, CA $265,000.00-$295,000.00 3 weeks ago Fremont, CA $179,000.00-$377,000.00 2 weeks ago Director, CMC Regulatory Affairs Biologics
South San Francisco, CA $238,000.00-$294,000.00 1 day ago Associate Director Regulatory Affairs APAC - Diabetes Care
Alameda, CA $146,700.00-$293,300.00 4 weeks ago Associate Director/ Director, Regulatory Affairs
Foster City, CA $170,000.00-$220,000.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr