Manager* Regulatory Affairs

Manager* Regulatory Affairs

• Act as local/regional regulatory expert as part of the BioNTech Türkiye entity and link to the global Regulatory Affairs organization 
• Close collaboration with the global Regulatory Affairs organization to ensure implementation of the global strategy for new marketing authorizations, lifecycle management activities, and clinical trial applications 
• Point of Contact (PoC) with local Turkish competent Health authorities 
• Preparation and submission of regulatory documentation according to national requirements, and supporting activities for marketing authorization applications, line extensions, variations, priority applications, clinical trial applications as well as for GMP Inspection applications 
• Preparation or update of product informative texts (SmPC, PIL, Labeling) in local language
• Assess the local requirements and propose the optimal regulatory strategy for local authorizations in alignment with the Global Regulatory Lead (GRA) and GRA CMC Lead, execute agreed regulatory strategy. The strategy needs to consider local regulatory requirements and regulatory commitments, as well as ensure continued alignment with market needs and the further product development post-marketing.
• Plan, prepare and conduct interactions with Health Authorities as appropriate in coordination with global GRA Lead
• Ensuring alignment between regulatory objectives and project timelines
• Regulatory intelligence: monitor regulatory and competitive landscape in Türkiye; analyze the impact of regulation changes for BioNTech’s products; collect, evaluate and disseminate relevant updates as appropriate. Provide regulatory advice to global stakeholders in support of strategy development.
• Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc, as appropriate.
• Support of definition of local regulatory processes applied for maintenance of Marketing Authorisation(s) and drug life cycle management.
• Manage BioNTech-internal electronic submission, information and compliance systems, as assigned.

What you have to offer:

Education:

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent).

Professional experience and skill:

• At least 3 years professional working experience in Regulatory Affairs, including CMC, during clinical development, registration and post-marketing for medicinal products, preferably Biologics and Vaccines
• Experiences in interactions with Turkish authorities 
• Profound knowledge in global and local regulatory regulations 
• Extensive experience in preparation and revision of regulatory documents, incl. CMC, local labelling, artworks as well as GMP inspection application documents
• Experiences with collaborations with global multidisciplinary functions involved in clinical development, manufacturing and life cycle management
• Strong understanding of pharmaceutical business and regulatory governance/framework
• Tech-savvy user of computer systems and regulatory software 

Languages:

• Native Turkish speaker
• Fluency in English (written and spoken) is essential

Competencies:

• Pronounced team & communication skills; Ability to be agile and effectively collaborate in a dynamic, cross-functional environment 
• High degree of conscientiousness and diligence 
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity 
• Sense of ownership, honesty (proactive handling of errors) and integrity
• Ability to navigate through ambiguity and rapid growth and adapt to change and operate effectively
• Strong problem-solving skill, solution-oriented, and being able to quickly reprioritize and work in a start-up environment 

Benefits for you

BioNTech  is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Istanbul .  Apply now for your preferred job and location through our careers site .

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!