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Manager, Regulatory Affairs - Turkey

Locatie

Turkije

Functie/Business Area

Regulatory Affairs

Afdeling

Regulatory Affairs

Werkcategorie

Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Manager, Regulatory Affairs - Turkey

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:
In this Regulatory Affairs Manager role, you will be responsible for preparing, submitting, and following up on new Marketing Authorizations (MAs), GMP applications, and Life Cycle Management (LCM) applications for assigned products. You will ensure that all regulatory activities comply with Astellas policies and local, regional, and global regulations. Under the supervision of the T-MEA Lead RA, you will collaborate with internal stakeholders and build strong professional relationships with external bodies such as Health Authorities (HA) and relevant industry associations to ensure smooth regulatory processes and compliance with Turkish regulatory requirements.

Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities:
Monitor and share regulatory updates with relevant teams, ensuring compliance with local rules and company policies.
Develop and implement registration strategies for assigned projects, collaborating with Commercial, Market Access, and Supply Chain teams.
Provide strategic advice in Brand Team meetings to support product development and success.
Prepare and submit regulatory applications to health authorities, ensuring timely follow-up and compliance.
Review and approve Product Information, packaging, and promotional materials, ensuring they meet all regulations and standards.

Essential Knowledge & Experience:
Solid experience in Regulatory Affairs in Türkiye, including direct interactions with Health Authorities.
Knowledge of the regulatory environment, laws and regulations within Türkiye.
Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
Fluent in written and verbal business Turkish & English.

Preferred Knowledge & Experience:
Proven experience in preparing for and facilitating GMP inspections conducted by local health authorities.
Familiarity with Veeva Vault RIM (Regulatory Information Management) systems.

Education/Qualifications:
Bachelor’s degree, or equivalent.
Preferably with an MS degree in Pharmacy or other Life Sciences or equivalent.

Additional Information:
This is a permanent full-time position
Position is based in Istanbul, Türkiye.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 3 days per week in our Istanbul office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office
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.