CMC Regulatory Affairs Associate Line Manager Submission Excellence & Project Management (Synthetics)
The Regulatory Affairs Associate Director (Sub Ex) Line Manager possesses strategic leadership skills and is accountable for leading a team of Regulatory professionals ensuring 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.
The The Regulatory Affairs Associate Director (Sub Ex) Line Manager effectively applies the correct prioritisation in order to deliver the needs of both the AZ business and the customer. They provide operational, tactical and strategic 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 The Regulatory Affairs Associate Director (Sub Ex) Line Manager has an understanding of regional and/or global regulatory science and overall drug/biologic development processes and strategies.
The Regulatory Affairs Associate Director apply Lean Principles to ways of working and foster a positive working environment that supports continuous improvement and simplifications.
Main Responsibilities
- 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
- 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, resource planning and recruitment of staff, advise on 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 contribute 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: 1) Follow processes and work to standards, 2) Identify and solve problems 3) Define and implement improvements. Leaders will lead by example in creating a learning & continuous improvement culture.