Regulatory Portfolio Manager

Regulatory Affairs/Clinical Affairs London, United Kingdom


Descripción

We are hiring in our central London location for a talented Regulatory Portfolio Manager (known internally as RA Project Manager), who will do the hands-on regulatory activities associated with bringing new products to the market and life cycle management of key brands within the Perrigo UKI business.

There will be days worked in the office, due to the nature of the role, and days where the role is based from home.

We look for a candidate with a view of regulatory affairs as a business enabling function, supporting the internal stakeholders with interactive discussions on claims and campaign execution.

Main objective of the role is to manage assigned portfolio from a Regulatory point of view including projects (e.g. new MAA, site transfer) and post MAA activity. Ensure regulatory compliance of this portfolio (including medicines and non-medicines).

Your main duties and responsibilities also include:

  • Lead regulatory activities for assigned portfolio (e.g.: new MAA, post MAA activity) providing updates to business and reporting against project plans
  • Support brand management, including product name strategy, product information text, commercial activity (review of claims and advertising material) and pack design (artwork management
  • Develop regulatory strategies for new MAAs and product lifecycle maintenance activities, identifying risks and opportunities
  • Manage, execute and coordinate new MAA applications and support product lifecycle maintenance activities (including variations, renewals and safety updates).
  • Develop, roll out and maintain relevant internal procedures and best practices.
  • Ensure compliance of commercial activity and potfolio
  • Maintain the integrity of regulatory data in the relevant databases
  • Support Regulatory Associates and Senior Regulatory Associates

We need someone with a minimum of 5 years experience in a relevant regulatory environment, and a Bachelor or Master's degree in International Law, European Policies, Medical/Life sciences (or other relevant fields) or equivalent, relevant work experience.

Our ideal candidate needs to be:
  • Self-motivated, flexible and open to changing requirements
  • Highly driven with enthusiasm to meet requirements and cope under demanding pressure
  • Excellent spoken and written communication skills; able to represent Perrigo during interactions with external agencies
  • High accuracy and attention to detail.
  • Project management skills and the ability to work autonomously with guidance when required.
  • Ability to make decisions, problem solve, prioritise and multi-task
  • Stakeholder management skills
  • Continuous improvement and knowledge sharing focussed 

In return we offer a competitive package and continuous self development, working for a company who is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.