Senior Manager Regulatory Operations

Location:

Warsaw, PL, 02-653

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.

External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

Description Overview

Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems & processes and Regulatory data management & compliance.

Scope of the Role

The main objectives of the job are

To be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)
To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management system, eCTD publishing system)
To ensure RA data compliance with external requirements (main focus on Europe (SPOR, PLM)), through adequate processes and systems
To ensure RA data are current, accurate, usable and adequately linked to the relevant systems and processes in place in the business
To ensure appropriate support and training are in place for the relevant RA community concerning the systems and processes in use in the business
To drive optimisation of the systems and processes in use in the business;
To create and maintain processes that enable centralised medicinal publishing within the business unit (EU) with a view to expand those processes to the wider RA Community.
To support equipping the Regulatory Affairs function for further digital transformation including integration of data and Artificial Intelligence solutions
To manage a team of Operations Administrators (currently two team members but with planned future expansion)

Experience Required

Bachelor or Master’s degree in Life Science or Information Technology
8 years of experience in a relevant regulatory environment ideally part of it within an Operations role
Great communication skills.
Good project management skills.
‘Give it a go’ and positive attitude being keen on creative and problem-solving thinking whilst being thorough and focused with attention to detail.
The ability to support several concurrent projects/products in a flexible manner both autonomously and in a team environment.
Must be collaborative and able to influence change.
Inclusive and customer service oriented.

External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

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