Regulatory& Affairs Manager

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

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.

• 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