Manager, Clinical Trial, Global Regulatory Affairs (Alexion)

Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world, including Poland.

Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc

This is what you will do:

• Lead development and implementation of Clinical Trial Application (CTA) strategies in line with defined goals

• Lead day-to-day execution of clinical trials, following applicable Standard Operating Procedures (SOPs) and regulatory requirements

• Prepare CTA and coordinate development of response to Health Authorities questions, working in close collaboration with cross-functional colleagues

• Act as primary regulatory contact point with internal and external stakeholders for assigned clinical trials and represent regulatory function in the respective study teams

• Provide input on documents submitted to the Health Authorities, in accordance with relevant CTA guidelines and applicable commitments

• Manage other CTA activities, including, but not limited to, Trial Master File (TMF) maintenance and Quality Control

• Accountable for maintenance of compliant regulatory information and applicable tracker for their respective product(s)

• Participate in the development of processes and procedures relevant to the regulatory submissions

• Share information to project team colleagues on regulatory requirements

• May lead more complex clinical trial regulatory submissions, impacting different studies and therapeutic areas

• Contribute to development of global regulatory strategies through interaction with regulatory colleagues

You will be responsible for:

• Preparing regulatory submissions and acting as contact with regulatory agencies

• Participating in the development of processes and procedures relevant to the submissions

• Working collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycle

• Sharing information on regulatory requirements

• Continually monitoring the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications

• Performing regulatory intelligence related to clinical trials

• Supporting regulatory leads as regulatory representative within cross-functional teams to provide expert interpretation of relevant laws, regulations, and company policies

• Proposing improvement of the submissions process

You will need to have:

• Pharmacist or equivalent education in a life science (biology, chemistry, etc.)

• 5+ year experience in Regulatory Affairs within the pharmaceutical industry

• Good English oral and written communication skills

• Working knowledge of Agency regulations and industry standards pertaining to regulatory

• Experience on clinical trial application submissions, including with EU Clinical Trial Regulation

• Understanding of context and content of regulatory submissions and drug development process

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience liaising with regulatory agencies

• Good communication skills and collaborative mindset

• Ability to support projects to completion/ experience working in project teams

• Ability to work independently in a flexible environment to meet all regulatory requirements and business requirements

• Good project management and organizational skills

• Some travels might be required

• Experience with gene therapy programs and orphan developments is a plus

• Experience with regulatory inspections is a plus