Regulatory Affairs Manager - Trkiye
Regulatory Affairs Manager - Trkiye
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Job Description
About This Role
Joining us as Regulatory Affairs Manager you will work in close collaboration with the Trkiye Regulatory and commercial organization International Growth markets (IGM) team within Global Regulatory Affairs (GRA) and Chemistry Manufacturing and Control (CMC) Regional contacts as well as relevant local stakeholders.
In this role you will support the execution of regulatory activities for the assigned portfolio to ensure submissions and approval of new marketing authorization applications (MAAs) and postregistration variations within the agreed timelines under the supervision of your direct manager the Head of Regulatory Affairs Trkiye.
What Youll Do
- Registration Planning:
- Responsible for development and execution of registration strategy and plans for responsible product(s) in line with the regional regulatory strategy business plans and objectives
- Responsible for providing inputs of anticipated market specific regulatory issues for planned submissions local strategic guidance insights interpretation advice and updates related to Trkiye markets based on the local laws requirements and market practice.
- Dossier preparation submission and product Approval:
- Ensures execution of the agreed plans by coordinating the compilation of the local application files based on the documentation provided from IGM regional team in accordance to the local regulations. Follows up the evaluation processes at TTCK/MoH and ensures to fulfill their demands by foreseeing the risks & threats under the direction of Head of Regulatory Affairs Trkiye.
- Support Marketspecific file compilation & preparation of marketspecific documents
- Responsible for leading country regulatory submission activities for new products (CTD dossier preparation) & lifecycle management activities for the registered products assigned.
- Prepare priority application file and Follows up the evaluation processes at TTCK/MoH
- Ensure submitted product documents fully meet the local regulatory requirements for Trkiye market.
- Followup with the regulatory authorities during submission file review and ensure all questions /requests are provided/clarified/addressed within due time to ensure timely approval of the products.
- Ensure proper communication/archiving of all documents submitted to the local Health Authorities as required.
- Ensure consistent and transparent communication of regulatory timelines changes to timelines to Head of Regulatory Trkiye Regulatory Cluster Lead and business partners.
- GMP:
- Design appropriate GMP strategy to ensure earliest access prepare and submit GMP file in accordance with defined strategy in collaboration w/relevant internal stakeholders and closely followup with TTCK/MoH to ensure timely approval.
- Ensure maintenance of GMP certificates and take action to initiate GMP renewal in collaboration with relevant internal stakeholders
- Regulatory Compliance:
- Responsible for local and internal compliance to regulatory affairs relevant processes and systems.
- Raises awareness and advising impact of developing lifecycle asset activities to the Head of Regulatory Trkiye.
- Maintains products license and ensure all marketed products in the country are in compliance with local and corporate regulatory requirements
- Initiates manages and oversees the labelling and artworks development process (review approval implementation) within agreed timelines and local Health Authorities regulations.
- Review English labels and its Turkish translation and follow up with external supplier on proposed changes implementation.
- Manages local regulatory interactions with Health authorities to support product recall when necessary.
- Regulatory intelligence
- Provides local RA intelligence: Identifies current and emerging national regulations which impact marketing processes by actively evaluating regulatory policy rules and promptly informing related parties to add value to company objectives.
- Provides Competition intelligence and/or interpretation of business impact to local stakeholders as required.
- Regulatory Influence
- Establishes and maintains regular strong and trustworthy relationship with regulatory officials.
- Communicates with the local distributor to ensure optimized and compliant regulatory procedures.
Who You Are
You are a detailoriented regulatory professional with proven expertise in managing complex regulatory processes in Trkiye. With strong strategic thinking communication skills and a deep understanding of local pharmaceutical regulations you excel at building trusted relationships and driving successful outcomes in a dynamic environment.
Qualifications :
Required Skills
- Health Related sciences educational background (B.A or B.S; advance degree such as Masters would be a plus).
- A minimum of 57 years experience in Regulatory Affairs in Trkiye.
- Demonstrated strategic regulatory thinking and risk assessment capability.
- Broad knowledge of Trkiyes pharmaceutical legislation.
- Strong ability to understand interpret and apply local regulations guidelines policy statements and influencing/advising the operations accordingly.
- Experience with biotech products within neurology or a complex therapy area (preferably not just experience with established portfolios only).
- Proven track record of fasttrack registrations in Trkiye. Good experience in interfacing with relevant regulatory authorities.
- Effective and positive interactions with regulatory agencies and external network.
- Ability to assimilate new knowledge rapidly and deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound.
- Good Analytical skills accuracy and reliability.
- Ability to communicate effectively both orally and in writing with proven persuasive assertive and negotiating skills both internally and externally across functions.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
