Sr. Manager, Regulatory Process and Compliance

Empower the Future of Medicine at Alexion, AstraZeneca Rare Disease!

Join our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases.

We are seeking an experienced Sr. Manager of Regulatory Process and Compliance who will be a key member for the Global Regulatory Affairs (GRA) Process & Compliance team. .

The successful candidate will play a vital role in ensuring GRA operates in an efficient manner that is compliant with local and international regulatory standards.

The primary responsibility of this role is to act as the Business Process Owner (BPO) for assigned core regulatory processes.

The successful candidate will be required to develop and foster strong business relationships with cross-functional stakeholders in Alexion and AstraZeneca, to drive the development and continuous improvement of processes, technology and services for assigned core regulatory activities.

Examples include :

Document / dossier management and submission execution

Managing Health Authority interactions

Managing / communicating approved regulatory information to key stakeholders

Tracking Health Authority commitments and timelines

You will :

Develop, implement and maintain stakeholder support for assigned regulatory process areas and ensuring compliance with applicable industry regulations and Alexion policies

Partner with Process Area Leads / Subject Matter Experts to ensure customer requirements are understood, critically evaluated, prioritized and addressed for assigned core regulatory processes.

Provide management and oversight of GRA’s quality system to ensure all GRA controlled procedures and associated materials for assigned core regulatory processes are managed compliantly

Develop and maintain Key Performance Indicator compliance record dashboard(s) to identify risks

Ensure accurate and up to date records are maintained in Veeva Vault, including the coordination and ownership of core regulatory processes

You will need to have :

Bachelor’s degree in a scientific or technical discipline with at least 5 years relevant experience

An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing)

Ability to manage multiple stakeholders and build team relationships to collaborate in a global team environment at all levels of the organization

Experience authoring standards documents (Standard Operating procedures) or process maps

Experience with the development, implementation, maintenance, and ongoing customer support for regulatory processes.

Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organizations

Experience with Veeva Vault preferred

Detail oriented

Excellent written and verbal communication skills

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.

In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office.

But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

Great People want to Work with us! Find out why :

Date Posted

04-Sept-2024

Closing Date

17-Sept-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact .

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