Cambridge, UK
Posted by: Astra Zeneca
14 Mar
13 May expires

CMC Regulatory Affairs Senior Director and Group Manager

Cambridge, UK
Job Description

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 Commercialisation 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 crafted 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 collaborators to deliver the overarching global regulatory strategy. The role holder will demonstrate strong leadership skills and coach, empower and mentor team members, encouraging collaboration and engagement with team members.


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 customers, using these to maintain competitive advantage.



  • To lead a team (7-12 staff) primarily at Director & Associate Director level 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 authorities 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 consistently meets 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 sophisticated non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory teams.

  • Will handle high level risk by making sophisticated judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding.

  • Ensures effective regulatory representation in partnership with technical experts at health authority meetings and clear documentation of the discussion and agreements.

  • Direct contact 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 CMC Reg Affairs 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 TA VP and Global Regulatory Leaders (GRLs), and customer function managers (e.g. BPD, Pharm Sci, PTD and Operations). Regularly review such allocation to ensure optimum utilisation 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 coordinate emerging trends into regulatory strategies

  • 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 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.

Job ID Reference
Desired Skills & Experience
  • Experienced graduate or PhD in a scientific subject area, typically chemistry, pharmacy or a biological science.

  • A significant knowledge and understanding of the science and technology associated with (bio)pharmaceutical development and manufacture.

  • Typically ten years 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 for the role:

  • Experience of leading or contributing to significant change programs

  • Experience of Product Development, technical operations and associated resource requirements

  • Extensive in-depth knowledge of regulatory procedures and processes

  Gaithersburg, Maryland, USA
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
 Cambridge, UK