Director, CMC Regulatory

Job Description

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 Director, CMC RA to add to our hard-working team in Gaithersburg, MD. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

What You’ll Do

In this role, you will represent CMC Regulatory in cross-functional teams across the business such as Biopharmaceutical Development Project teams, Global Regulatory Strategy Teams, and Clinical Supply Chain/Global Supply Teams. You will lead and supply to the development of new guidance, policies, and processes and act as a key contact for identified customer functions to facilitate high-quality partnerships both internally and externally.

The CMC Regulatory Affairs Director will collaborate with other Project Leads/disciplines to support key activities on complex projects as well as contribute to and lead regulatory CMC advise of business-related projects across the life cycle, including clinical development/new molecular entities/line extensions/CMC post-marketing management for synthetics and/or biologic products where appropriate. In this role, you will be expected to have effective levels of interactive communication within the project team and directly advise and influence those within the team. You will also manage risk using evaluative judgments in complicated or novel situations and ensure the application of global CMC regulations and guidance within AstraZeneca.

Responsibilities:

• Provide CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.

• Provide operational, tactical, and strategic CMC RA expertise and direction for CMC submissions across the lifecycle of a product.

• Where necessary lead CMC related interactions with Health Authorities globally.

• Accountable for the provision of expert regulatory strategic guidance in support of Operational initiatives, for example complex/accelerated projects and/or post approval changes.

• Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca.

• Lead knowledge sharing and provide coaching both within CMC RA and wider business functions. Lead/contribute to Community of Practises across the groups or within a business unit.

• Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.

• Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC.

• Support the implementation of agile and novel approaches in CMC Dossier Management that drive new ways of thinking to enhance flexibility efficiency and flexibility.

• Participate and /or lead due diligence teams as necessary.

• Lead /contribute to cross SET non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.

• Conduct activities and interactions consistent with Company Values 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.

• 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.

Requirements:

• Bachelors degree in Science, Regulatory Sciences or Pharmacy.

• 7 years experience in Regulatory/Drug development (Industry or Health Authority)

• Breadth of knowledge of manufacturing, project, technical and regulatory project management.

• Strong understanding of regulatory affairs globally

• Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products

• Stakeholder & Project management

• Professional capabilities: Regulatory knowledge

Desirable Skills/Experience:

• Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.

• 10 years experience in Regulatory/Drug development (Industry or Health Authority)

• Business, financial and supply chain understanding/ awareness

• Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies, antibody drug conjugates or radiopharmaceuticals

• Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.

At AstraZeneca, we are recognized as experts working at the forefront of science. Our high visibility roles allow us to make an incredible impact. We thrive with increased responsibility and are dedicated to helping patients who need it the most. Our supportive yet challenging environment fosters continuous improvement and innovation. We embrace global opportunities and work across all Therapy Areas to deliver life-changing medicines.
Ready to make a difference? Apply today and join our team!

The annual base pay (or hourly rate of compensation) for this position ranges from $186,233 to $279,349. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.