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Vacatureadvertentie

Manager, Regulatory Affairs Product Information & Artwork - MEA

Locatie

Turkije

Functie/Business Area

Regulatory Affairs

Afdeling

Regulatory Affairs

Werkcategorie

Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Manager, Regulatory Affairs Product Information & Artwork – MEA

About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

The Opportunity:
As Regulatory Affairs (RA) Product Information & Artwork Manager TMEA you will be responsible for the preparation of local Product Information (PI), abbreviated PI, and Artwork, on a timely basis according to the applicable internal and external requirements, and the oversight of their implementation to secure a continuous supply of products in compliance with the registration.

Hybrid Working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Activities:
Single point of contact of the affiliate for the preparation of country specific PI/AWs for i MAAs or updates
Interaction with other cross functional roles in the delivery and management of labelling text through the appropriate processes and systems
Communicate, plan, prioritize and deliver labelling documents according to company targets and submission requirements; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
Supporting the use of relevant tools and technologies within the course of the label development and translation process
Coordinate the review and approval of the (abbreviated) prescribing information as mandated by Astellas procedures and country legislation.

Essential Knowledge & Experience:
Proven experience in a similar role with a Multinational Pharmaceutical Corporation
Knowledge of the Product Information, artwork and fundamentals of regulation framework in the field of medicines in the region
Good cross-functional, project management and planning skills
Should possess a meticulous attention to detail.
Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment.
Strong written and verbal communication in English.

Preferred Knowledge & Experience:
Proficiency in PC use with regard to word-processing, spreadsheets, database application, and internet.

Educations/Qualifications:
MS Degree in Pharmacy or other Life Science or equivalent.

Additional information:
This is a permanent, full-time position.
The position could be based out of either Cairo, Egypt, or Istanbul, Turkey depending upon the current location of the candidate.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 3 days per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer:
A challenging and diversified job in an international setting.
Opportunity and support for continuous development.
Inspiring work climate.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.