CMC Regulatory Affairs Senior Director & Group Manager Project Leadership

Be trusted and empowered to be the best you can be! Here at AstraZeneca, we thrive in our inclusive and ambitious environment. We draw on our knowledge to take smart risks and uncover creative ways to better deliver for our patients and our business.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and own the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.

We are seeking a Senior Director & Group Manager, Project Leadership to add to our hard-working team in Gaithersburg, MD.

What You’ll Do

The role reports to the Executive Director, CMC RA and is responsible for leading a team of regulatory professionals responsible for delivery of global CMC Regulatory strategy and leadership across the product lifecycle. The role provides strategic technical CMC regulatory expertise and oversight to support the Research, Development and Commercialization of specific drug technology platforms and to ensure adequate regulatory resource and capabilities for projects in line with designated technology platforms within the portfolio.  This role ensures that the technology platform strategies are designed to deliver positive regulatory outcomes which meet the needs identified by the business, markets and patients. 

The role holder possesses strategic leadership skills, has a deep understanding of the technical aspects of drug technology platforms, global regulatory science, the overall drug development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders to deliver the overarching global regulatory strategy. The role holder will demonstrate strong leadership skills and coach, motivate and mentor team members, encouraging collaboration and engagement with stake holders. 

The role holder may also have accountability for driving regional CMC regulatory intelligence and advocacy in alignment with global CMC priorities and work with relevant platform technology leads to ensure development of effective global CMC regulatory strategies.  Establishes and develops external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage. 

Responsibilities:

• To lead a team (7-12 staff) primarily at career level F & E to their full potential; providing coaching, mentoring, skill development and performance feedback to staff working on projects.   
• To ensure that the group has the regulatory and technical capabilities to progress the portfolio. 
• Will be accountable for delivering the CMC Regulatory Strategy for a complex portfolio of drug projects spanning Research, Development and Commercialisation.   
• Partner with Research, Development & Manufacturing experts to build strategies for development of drug technology platforms and identify activities to define effective regulatory strategy on a global basis taking into account regional differences.   
• Work with the CMC RA project leads to align on the regulatory strategy for products and ensure it consistency with the drug technology platform strategy.   
• Works collaboratively with the global/regional/local regulatory affairs staff and trade associations to influence developing views/guidance within leading Health Authorities within a specific region. 
• Will ensure effective contribution to Reg Strategy Documents. 
• Lead complex non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory Excellence (GRE) when necessary.  
• Will manage high level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding.  
• Ensures effective regulatory representation in partnership with technical experts at all health authority meetings and clear documentation of the discussion and agreements 
• Interact directly with internal and external senior management, including senior-level officials from regulatory authorities. Serve, at all times, to improve AZ’s standing with regulatory authorities. Represent Reg CMC in communications, meetings or other interactions with internal and external senior-level influencers, as needed. Act as a credible, influential and respected company spokesperson. 
• Ensure the appropriate deployment of CMCRA staff to projects in consultation with the relevant TAVP and Global Regulatory Leaders (GRLs), and customer function managers (e.g. BPD, Pharm Sci, PTD and Operations). Regularly review such allocation to ensure optimum utilization and development of CMC staff
• Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical or strategic planning. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation. Monitor changes in the global regulatory environment and oversee process for incorporation emerging trends into sound regulatory strategies 
• Will lead Due Diligence activities on behalf of Reg CMC.   
• Lead knowledge sharing and provide coaching both within CMCRA and where appropriate to other AZ functions or external to AZ 
• Drive succession planning for key roles 
• As a member of the extended CMC RA LT to contribute to the development of functional goals, strategies and improvement objectives 
• Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards 
• Recruitment & development of high quality regulatory professionals 
• Carry out main role responsibilities, ensuring compliance with AZ Corporate Responsibility policies. 
• Accountable for the performance of the team and meeting budget targets 
• Conduct activities and interactions consistent with Company Values and collaboration in the workplace 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. 

In addition, for Managers and Project Team Leaders: 

• 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) fostering 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 expected 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 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. 

 Requirements:

• Bachelors degree in Science, Regulatory Sciences or Pharmacy. 
• 10 years experience in Regulatory/Drug development (Industry or Health Authority)
• A significant knowledge and understanding of the science and technology associated with (bio)pharmaceutical development and manufacture. 
• Experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in (Bio)Pharmaceutical or Analytical Development, Quality Control, Manufacture, also considered. 
• Has successfully contributed to at least one major regulatory submission in the global environment. 
• Significant project or line management experience in a relevant environment. 
• Ability to establish and foster excellent cross functional collaborations and communicate at multiple levels of the organization 

Desirable skills:

• PhD in Science, Regulatory Sciences or Pharmacy. 
• Experience of leading or contributing to significant change programs 
• Experience of Product Development, DPOM and associated resource requirements 
• Extensive in-depth knowledge of regulatory procedures and processes 

Next Steps – Apply today! 

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.