REGULATORY AFFAIRS SPECIALIST

Descripción del puesto.
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at (COMPANY NAME) on our webpage Life at (COMPANY NAME) | (COMPANY NAME) Job Purpose * Obtaining marketing authorization approval and lifecycle management of products under its responsibility ensuring compliance with national/European legislation and internal SOPs/WoWs * Back-up of local responsible for Artwork Management using Harmony & GLAMS systems.
coordination of packaging materials, new product introduction (NPI, new presentation pack, new indication, new line extension) with the objective of assuring its continuos update, in compliance with the legislation and local procedures to maintain continuous supply.
In this role, you will...
* Management of submission and follow-up of MAA requests, variations, renewals and MAH transfers until regulatory approval with National Authority for products under its responsibility * Share with local stakeholders' regulatory timelines on new products/line extensions in pipeline/product already approved, including relevant regulatory information regarding competitors and submission and management of abbreviated risk minimization measures with local Authority (when applicable) * Support and coordination with local Co-Promoted 3rd party ensuring regulatory compliance and ensure updating of Regulatory Information Management System/KPI input when required.
* Back-up of local responsible for Artwork Management.
responsible for the preparation and sending of the due documentation for the NPI, New Packs, Line Extensions, updates of current MA for the creation of new packaging components for marketed products.
Coordination of the new artwork proofs between Regional Service Center or local Agency and the local RA team and Supply Chain, to comply with the regulatory requirements (local and (COMPANY NAME)) for their implementation * Review and approval of packaging materials to confirm they are in compliance with the current legislation/internal SOPs & WoWs * Management of payment of regulatory fees to National Authority.
Management and coordination of CPP requests and Participation on the training plan for new RA Trainees Why you? Basic Requirements We are looking for professionals with these required skills to achieve our goals.
* Minimum Level of Education.
Degree/Master's degree * Area of Specialisation.
Pharmaceutical Sciences * Experience in Regulatory Affairs Area * High level of English Preferred Requirements.
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply.
* Ability to work in a team * Sense of responsibility * Good knowledge of information technology as user Job Posting End Date.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Why Us? (COMPANY NAME) is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.
billion people by the end of .
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making (COMPANY NAME) a place where people can thrive.
We want (COMPANY NAME) to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our (COMPANY NAME) leadership reflects our (COMPANY NAME) workforce.
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(COMPANY NAME) is an Equal Opportunity/Affirmative Action Employer.
All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of (COMPANY NAME).
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