Shire Regulatory Affairs Country Lead Turkey in Istanbul, Turkey
Regulatory Affairs Country Lead TURKEY is responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.
Develop effective relationships with local commercial organisation and service providers in TURKEY.
Provide effective liaison with the regulatory agencies in the country directly or service providers, ensuring escalation of key issues where required.
Provide regulatory guidance and advice on local country regulatory environments;
Provide assessment of the impact of new and changing regulations/requirements in TURKEY.
Use external resources to assist with the above tasks to not only meet timelines but expediting the time to market.
Manage Country Regulatory Team
In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management.
Ensure market applications, variations, post approval reporting obligations and general product life cycle management support for TURKEY are done on time.
Prepare and maintain project plans and timelines of approvals and planned submissions.
Prepare (as needed) and review key application components and meeting materials and chair/attend meetings with regulatory agencies and participate in agency inspections as required.
Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.
Interact with distributors, local agent and regulatory agencies to resolve related review questions
Act as a point of contact for the assigned projects and as interface with key corporate functional areas
Ensure compliance of regulatory activities in TURKEY consistent with Country laws and Shire internal protocols and procedures (CMLR, Labelling compliance, etc) in coordination and liaison with GRA labeling and Ad/Prom Groups
Develop relevant regulatory department local operating procedures (CMLR, etc)
Ensure regional regulatory documents, record keeping in secure, comprehensive manner
Ensure that all local product information used locally are up to date
Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements
Develop effective working relationships with business partners in TURKEY
Support the Senior Director, EAMEA Head and International RA team on specific projects as requested.
Part of Country Leadership Team
Education and Experience Requirements
Science degree required, higher degree preferred.
7-10 years regulatory management experience in international regulatory affairs and/or drug development . Experience in development and registrations of biotech product is a plus
Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility
Working experience within the TURKEY, relevant knowledge of other European or International regions is an advantage
Key Skills, Abilities, and Competencies
Be pro-active, prioritise and able to work with minimal supervision.
Must be able to work in a fast paced environment with demonstrated ability to deal with competing tasks and demands.
High cultural awareness and sensitivity
Effective communication skills in order to present effectively, both verbally and in writing, scientific and strategic concepts.
Critical thinking ability and good judgement
Very good English skills
Complexity and Problem Solving
Makes most decisions independently and exercises strong judgment, leading to the resolution of complex regulatory/business issues, referring to Line Management where required.
Will make considered and strategic recommendations within the range of experience but seeks advice and/or guidance where the decision requires it.
Internal and External Contacts
The position reports to the Senior Director EAMEA Head.
Internal and external job contacts related to the position include project team members, cross functional teams, local and regional commercial senior management, regulatory agency personnel, and company consultants/business partners/distributors.
Other Job Requirements
• Good level of English (both writing and speaking)
• Proficiency in MS Office tools, especially MS Excel and PowerPoint
• No restriction to travel (both domestic and international)
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.