CMC Regulatory Affairs Senior Director and Group Manager
Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
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 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.
Education, Qualifications, Skills and Experience
Essential for the role:
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
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Competitive salary and benefits package on offer.
Where can I find out more?
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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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.