Senior Regulatory Affairs Associate - London, United Kingdom - Perrigo

Perrigo

Verified Company

London, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.

Help us do it.

Description Overview:

In this role you will be handling licensing and post marketing activities for the centrally managed medicinal products mainly in the Nicotine Replacement Therapy (NRT) and Gastrointestinal (GI) categories in Perrigo's International business division (mainly EU) (CSCI)

Exposure within EU regulatory framework
Lead regulatory activities for assigned brand(s); providing updates to Category team and reporting against project plans
Support brand management, including product name strategy, core product information text, review of claims, global advertising material and pack design
Develop regulatory strategies for new MAAs and product lifecycle maintenance activities, identifying risks and opportunities.
Develop, roll out and maintain relevant internal procedures and best practices.
Maintain the integrity of regulatory data in the relevant databases.
Carry out any other regulatory tasks as required.
Support the RA Lead of Cross functional projects across the CSCI business and support on establishing optimized ways of working

Scope of the Role:

In this role you will be handling licensing and post marketing activities for the central NRT and GI categories in CSCI.

Main duties and responsibilities include:

To manage Regulatory Affairs projects as required to meet business needs
To ensure compliance with legislation in place for the regulation of medicines
To assist in any area of Regulatory Affairs at corporate level

Experience Required:

Bachelor's degree in scientific discipline
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work collaboratively under supervision and independently, in a fastpaced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Results driven and keen attention to details
You should be familiar with working in CCsystems (e.g. TrackWise) and eCTD publishing tools.
While every business thinks it's different, Perrigo truly is uniquely positioned within healthcare; operating across branded and pharmaceutical environments, with a strong innovation department, all supported by our worldclass manufacturing and distribution. All Perrigo employees are expected to live the Perrigo company values.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in _
_English__ and _
_Spanish__ and will be provided in other accessible forms for persons with disabilities._ #DIV