Regulatory Affairs Portfolio Manager

Regulatory Affairs/Clinical Affairs London, United Kingdom Barnsley, United Kingdom


Descripción

Perrigo Internal Job Title  - Regulatory Affairs Project Manager

ROLE PURPOSE

We are hiring in our central London location ((flexible hybrid working) for a talented RA Project Manager who will be responsible for the hands-on regulatory activities associated with bringing new products to the market of store brands within the Perrigo UKI business. As a RA Project Manager, you will also be responsible to supervise direct reports.

KEY RESPONSIBLITIES

  • Lead Regulatory Affairs Projects; providing updates to business and reporting against project plans.
  • Develop regulatory strategies for new MAAs and NPD projects, identifying risks and opportunities.
  • Complete due diligence on time for any assigned product dossiers, identifying risks and opportunities.
  • Manage, execute and co-ordinate new MAA applications/ NPD projects. Including product name strategy, product information text, review of claims, advertising material and pack design.
  • Develop, roll out and maintain relevant internal procedures and best practices.
  • Maintain the integrity of regulatory data in the relevant databases.
  • Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes
  • Manage a team of a regulatory affairs associates.

MINIMUM REQUIREMENTS

Typically, approx. of 5 years in the field of regulatory affairs, with some supervisory experience.
University Degree or equivalent required.

Must have strong experience in CMC and pharmaceutical life cycle management. Good interaction skills with internal and external stakeholders. Ability to multi-task and handle complex parallel projects, with high accuracy and attention to detail.

Desirable to have experience in due diligence of dossiers.

While every business thinks it’s different, Perrigo UK and Ireland truly is uniquely positioned within healthcare; operating across branded, store brand and pharmaceutical environments, with a strong innovation department at our headquarters in Belgium, all supported by our world-class manufacturing and distribution. All Perrigo employees are expected to live the Perrigo company values and operate in line with the UK&I behaviours.


Perrigo Company 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.

#LI-Hybrid

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.