Manager, Regulatory Affairs Product Information

2 weeks ago

القاهرة, Egypt Astellas Pharma Europe Full time

**About Astellas**:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

**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 iMAAs 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**:
**Educations/Qualifications**:

- MS Degree in Pharmacy or other Life Science or equivalent

**Additional information**:

- This is a permanent, full-time position.

**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.

**Job Types**: Full-time, Permanent

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