Senior Director, Global Regulatory Lead – Oncology
Takeda
5 hours ago
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Corporate Functions
How you will contribute:
- Lead global regulatory strategy for assigned programs across development stages; provide strategic, operational, and tactical regulatory insight for complex global oncology projects.
- Own complex and potentially multiple projects within the Oncology TAU; interface with the Global Project Team (GPT) to support cross-functional objectives.
- Serve as Global Regulatory Lead (GRL)/Franchise GRL on cross-functional teams for priority programs.
- Lead Global Regulatory Teams (GRT) to develop innovative global regulatory strategies aligned with applicable regulations.
- Act independently under direction of a Global Regulatory Portfolio Lead and/or TA Head; participate in/lead initiatives; coach and mentor GRT members.
- Ensure alignment of global regulatory strategies with the Leadership Team; present assessments and recommendations.
- Keep project teams and stakeholders apprised of developments impacting regulatory success.
- Accountable for US FDA submissions and approvals; may serve as primary FDA point of contact.
- Ensure submission execution on time and with high quality, including major submissions (NDA/BLA/MAA).
- Collaborate with all regions to create and execute global regulatory strategy.
- Partner with global market access on value evidence topics with regulators/HTA bodies.
- Develop/author and execute global regulatory strategies for complex strategies; may oversee execution.
- Monitor/anticipate regulatory and access environment trends; strengthen development plans.
- Demonstrate leadership behaviors; may lead due diligence regulatory assessments; identify/propose solutions for resource gaps.
Minimum Requirements/Qualifications:
- BSc/BA in scientific discipline (strongly preferred).
- Advanced degree (PharmD/PhD/MD) strongly preferred.
- 12+ years pharmaceutical industry experience (inclusive of 10 years regulatory, or 8+ years regulatory/related).
- Experience reviewing/authoring/managing components of regulatory submissions (including late-stage assets).
- Solid knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
- Ability to interpret complex scientific issues and data as it relates to regulatory requirements and strategy.
- Strong oral/written communication; manage timelines; negotiation skills; integrity and adaptability.
- Strong independent regulatory strategy skills; proactive issue identification and risk-mitigation solutions.
- Ability to work well with others and within global teams; bring teams together for common objectives.
Compensation & Benefits (explicitly stated):
- U.S. base salary range: $208,200.00 - $327,140.00
- Eligible for short-term and/or long-term incentives; medical/dental/vision, 401(k) with match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
- Lead global regulatory strategy for assigned programs across development stages; provide strategic, operational, and tactical regulatory insight for complex global oncology projects.
- Own complex and potentially multiple projects within the Oncology TAU; interface with the Global Project Team (GPT) to support cross-functional objectives.
- Serve as Global Regulatory Lead (GRL)/Franchise GRL on cross-functional teams for priority programs.
- Lead Global Regulatory Teams (GRT) to develop innovative global regulatory strategies aligned with applicable regulations.
- Act independently under direction of a Global Regulatory Portfolio Lead and/or TA Head; participate in/lead initiatives; coach and mentor GRT members.
- Ensure alignment of global regulatory strategies with the Leadership Team; present assessments and recommendations.
- Keep project teams and stakeholders apprised of developments impacting regulatory success.
- Accountable for US FDA submissions and approvals; may serve as primary FDA point of contact.
- Ensure submission execution on time and with high quality, including major submissions (NDA/BLA/MAA).
- Collaborate with all regions to create and execute global regulatory strategy.
- Partner with global market access on value evidence topics with regulators/HTA bodies.
- Develop/author and execute global regulatory strategies for complex strategies; may oversee execution.
- Monitor/anticipate regulatory and access environment trends; strengthen development plans.
- Demonstrate leadership behaviors; may lead due diligence regulatory assessments; identify/propose solutions for resource gaps.
Minimum Requirements/Qualifications:
- BSc/BA in scientific discipline (strongly preferred).
- Advanced degree (PharmD/PhD/MD) strongly preferred.
- 12+ years pharmaceutical industry experience (inclusive of 10 years regulatory, or 8+ years regulatory/related).
- Experience reviewing/authoring/managing components of regulatory submissions (including late-stage assets).
- Solid knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
- Ability to interpret complex scientific issues and data as it relates to regulatory requirements and strategy.
- Strong oral/written communication; manage timelines; negotiation skills; integrity and adaptability.
- Strong independent regulatory strategy skills; proactive issue identification and risk-mitigation solutions.
- Ability to work well with others and within global teams; bring teams together for common objectives.
Compensation & Benefits (explicitly stated):
- U.S. base salary range: $208,200.00 - $327,140.00
- Eligible for short-term and/or long-term incentives; medical/dental/vision, 401(k) with match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.