CSL Behring Regulatory Affairs and Market Access Manager (m/f/x) in Istanbul, Turkey
With operations in 35+ nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring (http://www.cslbehring.com) is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma (http://www.cslplasma.com/careers) , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Together into the Future...
In order to strengthen our Commercial Affiliate in Turkey, we are currently recruiting a
Regulatory Affairs AND Market Access Manager (m/f/x)
The Regulatory Affairs and Market Access Manager of CSL Behring Turkey is responsible for preparation and controlling of regulatory dossiers, following-up the regulatory processes, organizing and maintaining files, records and databases in Regulatory Affairs Department addition to follow-up, supervise and management of the consultants.
This person is also responsible for the pricing and reimbursement works of CSL Behring Turkey’s product portfolio; effective pricing& reimbursement and access management, getting optimum access to available product portfolio as well as upcoming launches.
Main Responsibilities & Accountabilities:
Management of the product lifecycle for all registered products of CSL Behring Turkey.
Preparation, submission and follow-up of registration &GMP inspection dossiers of new products and also maintenance of all existing portfolio
Coordination, preparation, or review of the registration &GMP inspection files and submission to the Authorities
Review labelling and labels for compliance with regulatory requirements
Submission and follow-up of technical/labelling variation and renewal applications
Preparation of responses to the Authorities for maintenance of the current portfolio
Annual follow up of the reference prices of CSL Behring Turkey product portfolio and preparation of pricing submissions in order to submit to Authorities
Preparation and follow up of reimbursement submission dossier for CSL Behring Turkey product portfolio
Identifying and cooperating with main key stakeholders at Government side
Collaborating with local and regional regulatory and market access teams in order to accelerate the new product launches.
Following-up the Regulatory, Pricing and Reimbursement Process
Contact with Local Authorities
Collaboration with internal stakeholders
Degree in pharmacy or life science (chemical engineering)
At least 5-7 years of experience in the pharmaceutical industry, of which 5 years of experience in Regulatory Affairs, Pricing and Reimbursement
Fluent in local language and very good command in English.
Strong understanding of and experience in Regulatory Affairs &pricing & reimbursement.
Strong knowledge of legislations in Turkey related with regulatory, pricing and reimbursement
Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive.
Able to work and communicate effectively and collaboratively across Affiliate functions and other global CSL functions and external partners/3rd parties.
Offer & Working Conditions:
Location : Istanbul, (office-based with possibility for remote work)
Travel: frequent travel to Ankara
Offer : Permanent contract
If you are interested in this challenging role, please apply online with your CV.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Worker Sub Type:
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement