Regulatory Affairs Specialist (1 Year Fixed-Term Contract)

Randstad Türkiye

We are looking for a ''Regulatory Affairs Specialist'' for our global business partner operates in pharmaceuticals sector.

Effective Regulatory Plan Execution and Strategy:

• Collaborate with the implementation of the regulatory plan in collaboration with GRA functions and affiliate cross-functions in alignment with affiliate business plans as well as regulatory requirements.
• Ensure submission and approval of high-quality regulatory applications within planned timelines.
• Maintain or support maintenance of clear metrics for Regulatory deliverables.
• Preparation and support of new applications to obtain marketing authorizations.
• Present affiliates perspectives and needs to global and regional regulatory contacts.
• Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
• Maintaining marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports).
• Effective collaboration with GRA Regional Regulatory Team supporting submission
• operational tasks to ensure high efficiencies of submission operations including planning process management, regulatory tools management, dossier preparation and product maintenance.
• Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.

Regulatory Compliance and Quality:

• Partner with GRA Regional Regulatory Team supporting submission operational tasks to ensure the use of regulatory tools (e.g. Regulatory Information Management) for submission tracking and management and update of regulatory requirements are up to date/accurate and are actively used to monitor regulatory plans.
• Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
• Implement robust processes to keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available.
• Ensure local quality system is in line with the global quality system and local regulations.
• Support regulatory quality audits and inspections and corrective and preventive actions as appropriate.
• Provide regulatory quality oversight for external parties e.g., regulatory affairs services providers, translators, graphic agencies as applicable.
• Perform assessment and communication of key regulatory compliance information to appropriate management and functions.

Labelling : 

• Perform the function of Alternate or Delegate Affiliate Labelling Responsible Person (ALRP),ensuring that product information complies with local regulatory requirements and that updated product information is submitted, approved and implemented within the designated internal and/or MOH timelines.
• Ensure adherence with global labelling procedures and document relevant exceptions to produce accurate and high-quality Product Information which is in compliance with global core labeling.

Process Improvement : 

• Support implementation of relevant internal regulatory initiatives.

Personal and Professional Development :

• Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
• Attend external regulatory meetings, trainings, workshops and conferences to develop technical expertise.

Minimum Qualification Requirements :

• Bachelor's degree in scientific or health sciences discipline.
• Knowledge of local/regional regulatory procedures and practices, and drug development process.
• Effective teamwork, communication and negotiation to establish positive networking and influence internally and externally.
• Demonstrated good information technology skills.
• Good knowledge of written and spoken English and local language, if applicable.
• Ability to adapt to internal and external challenges, anticipate risks and issue management.
• Excellent planning and priority setting skills.
• Effective time and project management.
• Effective communication and negotiation skills to establish positive networking and influence internally and externally.
• Strong knowledge of Quality systems.
• Strategic thinking and decision making.