Job Description

JOB TITLE: REGULATORY AFFAIRS DIRECTOR

CAREER LEVEL: F

Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development Be part of the team where you are empowered to follow the science Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..

ABOUT ASTRAZENECA

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

ABOUT THE TEAM

We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.

ABOUT THE ROLE

/ Capsule The Regulatory Affairs Director (Submission Excellence) Line Manager possesses strategic leadership skills and is accountable for leading a team of Regulatory professionals. They provide overall direction and are accountable for people management and development to ensure delivery of global CMC regulatory submissions for a product/group of products across the product lifecycle based on the needs identified by the business, markets and patients. They have a strong input to the strategic direction of CMC RA globally. The role holder is able to manage complex situations to ensure correct prioritisation in order to deliver the needs of both the AZ business, the customer and the future direction of CMC RA. They provide high level strategic, operational and tactical regulatory CMC expertise and direction to AstraZeneca product team in support of drug products. They have effective levels of interactive communication and manage risks using evaluative judgments in complicated or novel situations. They ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to development of new guidance, policy and processes. The role holder has an understanding of regional and/or global regulatory science and overall drug/biologic development processes and strategies. The Regulatory Affairs Director apply Lean Principles to ways of working and foster a positive working environment that supports continuous improvement and simplifications. They drive and promote one way of working across the CMC RA Submission Excellence organisation.

Typical Accountabilities

• To provide overall direction, develop and line manage a group of regulatory CMC experts within the CMC RA organisation. To have a strong input to the strategic direction of CMC RA globally. Will have a high level of interactive communication to set clear direction for the global staff, directly advising and influencing others at a high level.
• Accountable for recruitment, skill-development, coaching, and performance feedback of team members.
• Accountable for working collaboratively with peer line manager to ensure consistent ways of working with AZ line management policies and decisions
• Accountable for taking a holistic AZ perspective in decision making in e.g. complex resource situations
• Ensure project activities managed within the team are delivered to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
• Accountable for delivering the CMC Regulatory Submissions for a complex portfolio of drug projects across the product lifecycle. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Lead cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ.
• Manage risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding. Monitor changes in the global regulatory environment and oversee process for incorporation emerging trends into effective submission strategies.
• Assist in budget management and drive resource planning and coordinating the appropriate deployment of CMC RA staff to appropriate cross functional teams in consultation with the relevant function managers. Regularly review such allocation to ensure optimum utilisation and development of CMC staff.
• Lead knowledge sharing and provide coaching both within CMC RA and possibly to other AZ functions or external to AZ.
• Accountable for the delivery of regulatory initiatives and improvement programs aimed at ensuring compliance, continuous improvement, enhancing commitment to quality and improving profitability, ensuring that policy and standards meet regulatory requirements.
• Actively contributes to unit Leadership Team.
• Build effective networks across Regulatory, Technical and Quality organisations.
• As a Leader with accountability for GXP areas understand the legal and regulatory requirements of the role in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
• AstraZeneca drives business performance through continuous improvement, we therefore expect all employees to: Follow processes and work to standards, Identify and solve problems 3) Define and implement improvements. Leaders will lead by example in creating a learning & continuous improvement culture.
• Lead the implementation of consistent global practices in CMC documentation that drive an agile way of working and enhance flexibility , efficiency and productivity . learning from CMC submissions, regulatory questions, answers and approvals.
• Is adaptable and flexible to meet the needs of CMC RA and AZ Business.
• Pro-actively drives Product Leadership to identify and ensure adequate submission management resource.
• Collaborates with Product Leadership on future strategies

Education, Qualifications, Skills and Experience

• Bachelor\xe2\x80\x99s degree in a science related field and/or other appropriate knowledge/experience.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
• Proven leadership and program management experience.
• Proven track record of independently manage complex managerial tasks
• Proven track record of coaching and delegation capabilities
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high profile development program.
• Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership, decision making and excellent oral and written communication skills.
• Experience of people management.

WHY JOIN US? We believe there\xe2\x80\x99s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals. Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout SO, WHAT\xe2\x80\x99S NEXT? Are you already envisioning yourself joining our team? Good, because we\xe2\x80\x99d love to hear from you! Click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can. WHERE CAN I FIND OUT MORE? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.