This is an outstanding opportunity to join a rapidly growing global pharmaceutical company who are currently experiencing a strong period of growth with a number of products in early and late phase clinical trials.

They are looking to hire as Associate Director of Regulatory Affairs for their Oncology business Unit.

This a key role in the business and will require you to provide leadership and strong strategic input into multiple projects in the EU market.

The role covers the full life cycle of regulatory affairs and will require you to represent the EU oncology regulatory affairs team on global team meetings as well as lead interactions with health authorities.

In this role you will be required to:

Provide oversight for all regulatory submissions (CTAs, MAAs, CTA amendments, Variations, Scientific Advice briefing documents

Direct regulatory strategy and contribute to its outcome for the assigned projects and products

Be the main point of contact for health authorities' interactions

Oversee multiple Matrix teams to effectively manage early and late phase projects simultaneously

Provide strategic regulatory affairs insight on to global cross functional team meetings

focus on driving forward the clinical development process for key compounds assigned, by ensuring the timely submission of all clinical trial for New Active Substances

We are looking to speak to candidates with:

A strong EU regulatory affairs background with proven experience across early and late phase development as well as initial MAA and life cycle maintenance

Proven experience working on paediatric investigation plans (PIPS) and Orphan designations

Proven experience interacting with the EMA including leading and participating on HA meetings

Proven experience preparing scientific advice briefing documents

Proven experience developing and implementing regulatory affairs strategies for development and marketed products

Proven experience working with oncology products is highly desirable

This is a permanent opportunity which will enable to you to be a valued member of the team in a family feel environment. The role will offer you the chance to be a key stakeholder on multiple innovating projects allowing you to add to your already impressive regulatory affairs portfolio.

This role is paying a competitive salary and attractive package and comes with a large amount of home working flexibility which can be tailored to the individual needs of the candidate.

If you are looking for the next step in your career which will allow you to use your regulatory affairs expertise across the full life cycle of Regulatory affairs to deliver cutting edge treatments to millions of patients globally then apply today!

Job Title: Associate Director Regulatory Affairs OBG

Location: Hertfordshire, UK

Rate/Salary: .00 GBP Yearly

Job Type: Permanent

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