Regulatory Affairs Manager - Levant
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
Learn more at Astellas.com
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 2 days per week/month/quarter in ISTANBUL, TURKEY office
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- 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.
- This is an individual contributor position, full time, permanent position.
Role and 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
Required Qualifications
- 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
- BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
Preferred Qualifications
- Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, 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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