About Astellas:
At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
The opportunity:
As the Regulatory Affairs Manager - Levant, you will be reporting directly to the Sub-Regional Lead, Turkey Middle East Africa (TMEA) and be responsible to arrange the provision of regulatory expertise and execution of regulatory strategy & activities for new Marketing Authorizations (MAs) and Life Cycle Management of MAs in the territory. s.This is an individual contributor position and will be based out of Istanbul, Turkey.
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.
Responsibilities:
- Develop national regulatory submission strategy and planning for new MAA and Life Cycle management activities. Advise on optimal regulatory pathway & timelines, dossier content including CMC, Clinical and labelling, EAP/CDx.
- Initiate, review and approve Product information (SmPC/aPI/PIL/aRMM) & artworks
- Ensure timely preparation, submission to the HA and follow up of regulatory applications including preparation of regional/local specific documents and other tasks (eg translations).
- Ensure regulatory compliance & reputation. Develop and maintain professional relationships with relevant external contacts including the Health Authority and Trade Associations
- Review/approve promotional materials with an in-depth understanding of code
Essential Knowledge & Experience:
- Substantial experience within a similar Regulatory Affairs role ideally with a global pharma organization.
- Experience working with distributor markets & business partners across the Levant and Gulf region would be highly preferred.
- Knowledge of Regulatory landscape and procedures within the country/region
- Knowledge of the Regulatory compliance
- Strong communication skills with the ability to work through change management
Preferred Experience:
- Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
Education:
- BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
Additional information:
- This is a permanent, full time position
- The position is based in Instanbul, Turkey
- Candidates should be based in Instanbul, Turkey
- This position follows our hybrid working model. Role is blend of work from home and a minimum 2 days in Istanbul office. Flexibility may be required in line with business need. 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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