CMC Senior Director & Group Manager, New Products & Commercial Biologic Products

AstraZeneca - Gaithersburg, MD4.1

Location: Gaithersburg, US

Competitive Salary & Benefits

The CMC Regulatory Affairs Senior Director, Group Manager 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.

To provide 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 designed to deliver positive regulatory outcomes which meet the needs identified by the business, markets and patients.

The role holder will 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.

In this role, you will lead and manage a group of Regulatory professionals responsible for delivery of global CMC Regulatory strategy across the product lifecycle to contribute to the global drug project team's deliverables.

You will also develop and shape the strategic direction of the Reg CMC function, leading and implementing significant change projects for improved processes and performance.

Ensure the recruitment and development of staff and lead talent and performance management activities for the group.

You will oversee operational delivery and efficiency and ensure appropriate resource planning and staff assignment to support drug projects and business improvement projects.

You will establish and develop external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.

Accountabilities & Responsibilities:
Partner with Research, Development & Manufacturing experts to build strategy for development of drug technology platform and identify activities to define effective regulatory strategy on a global basis.

Work 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.

Partner with the Reg CMC project leads to align on the regulatory strategy for a product(s) and ensure it is consistent with the drug technology platform strategy.

Ensure drug technology platform global regulatory strategy take into account key regional considerations.

Line manage staff to their full potential; providing coaching, mentoring, skill development and performance feedback to staff working on projects. Ability to drive succession planning across Reg CMC.

Will be accountable for delivering the CMC Regulatory Strategy for a complex portfolio of drug projects spanning Research, Development and Commercialisation.

Will lead Due Diligence activities on behalf of Reg CMC. Will ensure effective contribution to Reg Strategy Documents.

Lead complex non-drug projects on behalf of Global Regulatory Affairs (GRA) when necessary.

Will manage high-level risk by making complex judgments, 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 sound regulatory strategies

Ensure 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.

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.

Ensure submission excellence across projects including knowledge sharing and leveraging and developing existing tools.

Assist in or lead budget management, resource planning and recruitment of staff in partnership with the Global Head of Regulatory CMC. Together with the Global Head of Regulatory CMC, advise on the appropriate deployment of Regulatory CMC staff to Regulatory Project Teams in consultation with the relevant TAVP and Global Regulatory Leaders (GRLs), and ensure the appropriate deployment of Regulatory CMC staff to customer Function project teams (e.g. BPD, Pharm Sci, PTD and Operations) 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 Regulatory CMC and Global Regulatory Affairs, Patient Safety & QA, and possibly to other AZ functions or external to AZ.

Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. ANGEL, and MCM.

Carry out main-role responsibilities, ensuring compliance with AZ Corporate Responsibility policies.

Minimum Requirements

Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science.
A significant knowledge and understanding of the science and technology associated with (bio)pharmaceutical development and manufacture.
Considerable 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, might also be 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
Skills and Capabilities

A broad understanding of regulatory application procedures and specialist knowledge in worldwide regulatory CMC requirements for development, license maintenance and renewal submissions.
A strong understanding of the regulatory affairs function and customer functions and business processes and how they contribute to achieving the overall objectives of AstraZeneca.
Ability to influence senior stakeholders, both internally and externally

Leadership capabilities:
Make effective and timely decisions even in difficult situations.
Understand, identifies, assesses and manages risks.
Ensure development opportunities for all employees and encourages them to take personal responsibility.
Demonstrate awareness of effect of own behaviours, needs and motives on other people
Use own values as guidance in work.
Problem solving: Deal with a wide range of problems that require complex judgments and innovative solutions. Problems will call for well-developed conceptual thinking.
Extremely high-level of interactive communication skills is required to negotiate, influence and challenge others as necessary. Will need particularly well-developed cultural sensitivity to influence the beliefs, opinions and behaviours of customers. Will represent AstraZeneca externally.
Good written and spoken English.
Organizational Behaviours

Customer focused:
Building sustaining win-win relationships with customers

Performance driven:
Working with a sense of urgency to deliver results.
Routinely sharing information and learning from past experiences to deliver better business results.

Teams passionate about winning:
Demonstrate leadership, take informed risks and set example for others.
If you are interested in this position, please apply by submitting your CV before 15th Dec 2018.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.