Director / senior manager regulatory affairs - united kingdom, scotland

we have an opening for a *director / senior regulatory affairs manager pharma. *the regulatory team provide strategic regulatory advice and hands-on operational support for drugs, biologics and advanced therapy medicinal products (atmps) including gene therapy products as well as medical devices and combination products. our experience covers all life cycle stages from development to registration and post-marketing activities.

*core responsibilities*

* leading regulatory activities on assigned projects

* develop and lead regulatory strategy

* ensuring regulatory compliance of assigned projects

* independent preparation of regulatory dossiers

* interactions with health authorities

* interactions with client contact persons

* coaching junior team members

*qualifications and requirements*

* master/phd in pharmacy, life sciences or equivalent

* minimum of 5 years regulatory affairs experience in in consulting or pharmaceutical industry

* hands-on experience and sound understanding of the regulatory processes

* analytical and systematic thinking, organization, business orientation and flexibility

* experience with early development projects, including pips, odds, authority meetings and maas under the centralized procedure

* global regulatory experience is a plus

* able to work independently and on own responsibility under pressure

* a highly motivated and open minded personality, able to work in an international environment

* excellent communication skills

* fluent in english; additional languages welcome

*we offer*

* a stimulating role in an award winning company (great place to work)

* active contribution to registration of innovative products

* continuous development and external educational trainings for each team member

* work in an energetic, motivated team

* rewards for outstanding accomplishments

would you like to join and contribute to an award-winning, successful and growing multi-cultural organization in the heart of europe and a world-leading region of the pharmaceutical industry? sfl group, a veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

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