Executive Director CMC Regulatory Affairs
Location
Gaithersburg, MD | United States
Job description
A Regulatory, Quality, and Compliance expert contributing to the strategic direction and management of the CMC Regulatory Affairs function. Responsible for the development and delivery of the global CMC Regulatory strategy for Synthetic Products within the Oncology therapeutic area across the development and commercial lifecycle. Will lead several teams of regulatory and compliance professionals and lead a large number of employees.
The Executive CMC Regulatory Affairs Director possesses strategic leadership skills and has a depth of knowledge and experience within the CMC Regulatory environment. Influential in cross-functional discussions with relevant senior internal and external collaborators to deliver the overarching global regulatory strategy for a large portfolio of development and commercial products, to secure approval, ensure continuity of drug supply, and maintain regulatory compliance. Has a significant impact on the achievement of AstraZeneca's financial and business goals.
- Partner with Research, Development, and operations experts to build innovative approaches for the development of current and future drug portfolios and identify activities to define effective regulatory strategy on a global basis.
- Contributes to the strategic development of the CMC Regulatory Affairs function, collaborating with senior colleagues across Regulatory Affairs, R&D, and Global Operations to ensure overall strategic alignment to meet AZ portfolio goals
- Works with Operations Supply Chain leadership to define strategy and priorities for optimization of commercial supply chain for a portfolio of products. Attends Supply Committee as needed providing Regulatory input into proposals impacting global supply
- Will sit on relevant Reg TA leadership team to drive close alignment between Reg TA and CMC RA strategic objectives, portfolio priorities, and capability development to meet future portfolio challenges.
- Represent CMC Regulatory in communications directly with internal and external senior leaders, including negotiations with senior-level officials from regulatory authorities. Serve, at all times, to improve AstraZeneca's standing with regulatory authorities, meetings, or other interactions with internal and external senior-level influencers, as needed.
- Be the TA/Business area point of contact for the Global Quality Head and attend Quality LT meetings as required
- Has accountability for ensuring GxP compliance across the TA/Business area ensuring implementation and maintenance of the QMS. Ensures no interruption to the supply of medicines to patients for regulatory compliance reasons.
- Monitor changes in the global regulatory environment and coordinate the process for incorporation of emerging trends into sound regulatory strategies - also to influence internal capability build.
- Play an active role in leading and crafting external policy development via industry groups and directly with regulatory agencies
- As a member of the CMC Regulatory LT ensure that CMC Regulatory maximizes its contribution to the achievement of business objectives, profitability, and return on investment. May have a direct contribution to the achievement of objectives across AstraZeneca more broadly.
- Coaches and delivers effective performance from direct and indirect reports crafting an encouraging work environment
- Ensures the CMC RA organization works collaboratively with the global/regional/local regulatory affairs staff and trade associations to accelerate patient access to medicines Globally.
- Has responsibility for Business Process Management of processes within the organization's remit and promotes an environment of continuous improvement within the organization.
- Will lead high-level risk by making complex judgments, developing innovative solutions, and applying a comprehensive cross-functional and industry understanding.
- Lead budget management, resource planning, and recruitment of staff for area of responsibility. Ensure the appropriate deployment of CMC RA staff to projects. Regularly review such allocation to ensure optimum utilization and development of CMC RA staff.
- Ensure effective knowledge sharing and mentoring across CMC RA.
- Ensure that own work is performed by appropriate SHE, quality, and compliance standards.
- Carry out main role responsibilities, ensuring compliance with AstraZeneca Corporate Responsibility policies.
- Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) encouraging a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
- Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
- Leaders with accountability for GXP areas are encouraged to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its efficiency.
Minimum Qualifications: - A bachelor's degree and ten years of experience in Regulatory Affairs, a with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in CMC Development, Quality Control, manufacture, or relevant roles in the Regulatory Agency
- Strong critical thinking and influencing skills at all levels across cultural interfaces
- Significant experience (5-10 years) in leading teams of people
- Strong leadership skills working in an international environment
- Strong communication and interpersonal skills
- Develops People and Organization - builds capability for the organization
- Acts Decisively - promotes effective decision-making
- Handling Change - challenges the status quo and transforms the organization for sustainable growth
Desired Qualifications: - Experience in leading or contributing to significant change programs
- Experience in Product Development, DPOM, and associated resource requirements
- Extensive in-depth knowledge of regulatory procedures and processes
If this sounds like the type of organization where you would like to grow your career and make a real difference to patients then we would like to hear from you; apply today!
Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next! Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn
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Date Posted 08-Jan-2024
Closing Date 04-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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