AstraZeneca Pharmaceuticals LP Director CMC Group Manager Submission Excellence, New Biologic Products in Gaithersburg, Maryland
Location: Gaithersburg, US
Competitive Salary & Benefits
The role holder will focus primarily on cross functional improvements to the systems and procedures for delivery and management of clinical trial and marketing applications for the Biologic Products. Leads and manages a group of Regulatory professionals responsible for delivery of global CMC Regulatory submissions across the product lifecycle to contribute to the global drug project team's deliverables. Develops and shapes the strategic direction of the Reg CMC function, leading and implementing significant change projects for improved processes and performance. Ensures the recruitment and development of staff and leads talent and performance management activities for the group. Oversees operational delivery and efficiency and ensures appropriate resource planning and staff assignment to support drug projects and business improvement projects. Establishes and develops external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.
Accountabilities & Responsibilities
Will be accountable for delivering the CMC Regulatory Submissions for a complex portfolio of drug projects spanning new molecular entities, line extensions and product lifecycle management. Will lead Due Diligence activities on behalf of Reg CMC.
Lead non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ.
Will manage 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 effective submission strategies
To provide overall direction, develop and line manage a group of regulatory CMC experts within the GRAPSQA organisation. To have a strong input to the strategic direction of Regulatory CMC, globally. Will have a high level of interactive communication to set clear direction for the global staff, directly advising and influencing others at a high level.
Works collaboratively with the global/regional/local regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. 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 senior management. Serve, at all times, to improve AZ’s standing with regulatory authorities. Represent Reg CMC in communications, meetings or other interactions with internal 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. Member of a CMC project team.
Contribute to or lead policy setting and strategy development in the regulatory CMC environment within and external to AstraZeneca. May lead key business improvement initiatives. May sit on external industry groups.
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 GRAPSQA, 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.
Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards.
Carry out main role responsibilities, ensuring compliance with AZ Corporate Responsibility policies.
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.
Solid experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the (bio)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
Makes effective and timely decisions even in difficult situations.
Understands, identifies, assesses and manages risks.
Ensures development opportunities for all employees and encourages them to take personal responsibility.
Demonstrates awareness of effect of own behaviours, needs and motives on other people
Uses own values as guidance in work.
Problem solving: Deals 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 are required in order 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.
User-level skills in computers and data bases.
Building sustaining win-win relationships with customers.
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 role 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.