Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all the companies molecules. This is a product facing role that leads the Oncology Solid Tumor Portfolio for the Oncology Global Regulatory Therapeutic Area in the Global Regulatory Affairs organization.
The purpose of this role is to provide management and leadership of the therapeutic area teams within Global Regulatory Affairs; to direct the development of global regulatory therapeutic area strategies, drive product development, global registration, and achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. Will also provide regulatory expertise and guidance to therapeutic area commercialization teams (e.g. Franchise Strategy Committee, FSC) and other governance bodies.
The Executive Director Regulatory Affairs for the Oncology Solid Tumor Portfolio is responsible for:
- Development and execution of global therapeutic area regulatory product strategies for the oncology solid tumor portfolio
- Representing Global Regulatory Affairs on the FSC and other key commercialization governance bodies
- Leadership and oversight of United States regulatory strategies, submissions, and interactions within assigned therapeutic area
- Direct the development of global regulatory strategy across the oncology solid tumor therapeutic area
- Advise the GRL in the development of global regulatory strategies and the USRL in the development of US regulatory strategies, including precedence, risk management and contingency planning
- Provide global oversight of all regulatory decisions within a therapeutic area
- Management review and approval of Global Regulatory Strategic Plan and United States Regional Regulatory Plan
- Participate and represent GRA on FSC, providing expert regulatory strategy and regulatory decision making
- Management review and approval of key documents for regulatory submissions
- Participate in the Executive Labeling Board (ELB) and contribute to the target product label, core data sheet, and regional labelling for relevant products
- Monitor, assess and communicate to staff and GRA SMT impact of relevant global regulations, guidances, and current regulatory environment
Health Authority Interactions
- Advise and direct GRL on global regulatory agency interaction strategies
- Oversee US FDA interactions within assigned area
- Interact and negotiate with key global regulatory agency officials
- Participate on core regulatory and cross-functional teams to ensure effective agency interactions
- Advocate for the company by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies
- Works externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
- Participate and represent the company on external partnership committees
- Oversee and participate in licensing/acquisition due diligence and other activities in partnership with companies Licensing groups
- Provide managerial leadership & direction to the global and United States regulatory teams within assigned area allowing appropriate prioritization of resources to achieve goals.
- Recruit and retain talented regulatory affairs professionals. Provide coaching, mentoring, and development of staff
- Ensure staff are compliant with company corporate and departmental training
- Disseminate relevant information to teams as appropriate
- Contribute to company goals development
- Accountable for delivery against goals assigned to group.
- Participate in budget and headcount planning
- Sponsor regulatory process improvements, initiatives and training
- Provide regulatory expertise to FSC, senior management review committees, governance boards, other cross-functional product meetings
- Exchange regulatory information with other Global Regulatory TA Head(s) and Regional Regulatory Heads on an ongoing basis (e.g. prior to relevant senior management review committees and governance boards)
- Communicate and ensure alignment of global functional and cross-functional goals and objectives
- Leadership skills
- Conflict management
- Directing others
- Managing diversity
- Managing and measuring work
- Building effective teams
Doctorate degree and 6 years of experience in regulatory affairs
Master’s degree and 10 years of experience in regulatory affairs
Bachelor’s degree and 12 years of experience regulatory affairs
6 years of direct managerial and/or leadership experience
- Demonstrated ability to lead teams
- Contemporary experience developing regulatory strategies for oncology programs, specifically in the solid tumor setting
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Comprehensive understanding of regulatory activities and how they affect projects and processes
- Demonstrable ability to set organizational direction & champion change and continuous improvement
- Proven ability to anticipate and mitigate against future strategic issues & uncertainties
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders
Our client offers the opportunity to devise, develop and implement creative global regulatory strategies to bring novel products to patients as quickly, robustly and efficiently as possible – and to shape the regulatory framework in which we operate.
Please answer the questions listed below and email them back to me with your updated resume to firstname.lastname@example.org Referrals are welcome!
- Do you have 10 plus years of Regulatory Affairs? Explain
- Are you open to Relocation to CA?
Diversifying the workforce nationwide since 1985.