Regulatory Affairs Manager

As a Regulatory Affairs Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Services Overview:

Regulatory Affairs Manager is responsible for coordinating the operational and strategic aspects of clinical trial submissions applicable for countries in scope of the EU CTR for internally managed, and/or outsourced, trials, including compound level coordination. They co-ordinate the EU CTR operational clinical trial submission strategy - and develops, drives and monitors timelines/milestones. They work with central teams and country teams to ensure all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.

Responsibilities include planning a compound and trial level EU CTR combined operational submissions strategy with relevant cross-functional involvement throughout the entire trial lifecycle. This role will be responsible for driving the discussions, consolidate input from all stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy. In addition, this role will be responsible for coordinating submissions in the CTIS portal.

This position interfaces with stakeholders internal and external to Global Operations functions, such as the CTIS Administrator, GCO Country Local Submission Coordinator (local point-of-contact), Clinical Trial Manager (CTM), Global development Trial Leader (GTL), Global Regulatory Clinical Trial Application Submissions Manager (Global CTA SM), CRO point of contact, and other relevant functional area stakeholders as needed. They collaborate closely with the GTL, CTM (if applicable), LPOC and CTA SM, and are a member of the Trial Team.

Major Duties/Responsibilities operations

•Lead the EU Submission strategy development, planning and delivery as a member of the Cross Functional Trial Team (CFTT)

•Clinical trial planning, submissions and notifications

•Financial planning and tracking

•Cross functional submission management

•Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Experience & Skills:

Required

• Global clinical research regulation knowledge and understanding, strong project planning/management expertise and effective communication skills.
• Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
• At the senior level, minimum of 5 years experience in the pharmaceutical industry or CRO.
• Proven track record in successfully managing multinational clinical trial submissions to Health Authorities.
• Proven track record in successfully managing multinational clinical trial submissions to Ethics Committees. 
• Demonstrated effective leadership to proactively drive cross-functional team(s), as well as delegation skills.
• Ability to independently manage multiple stakeholders. Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Effective verbal and written communication skills leading to successful team collaboration.
• Demonstrated strong presentation skills and effective stakeholder management.
• Proven ability to lead a team through formation stages, up to operating as a high performing team.
• Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong knowledge of standard Microsoft applications, willingness to learn new systems.
• Able to mentor less experienced staff in productive use of key systems

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.