For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Reporting to the Senior Director of Regulatory Affairs, the Director of Regulatory Affairs Turkey is responsible for providing strategic leadership and direction for regulatory activities across Gilead’s therapeutic areas in Turkey. This role requires cross-functional partnerships, to ensure that all projects have the appropriate local regulatory input and guidance.
The ideal candidate has expertise in local regulatory affairs, pharmacovigilance and quality systems. Moreover, they will have had extensive exposure across the Pharmaceutical or Biotechnology sector.
Role and Responsibilities:
- Develop, propose and agree local registration strategies based on regulatory requirements, product knowledge and company strategy.
- Primary contact with national authorities for regulatory issues regarding the company’s products (clinical trial applications, new marketing authorization applications and lifecycle maintenance applications).
- Design and seek alignment on innovative regulatory pathways for product development.
- Proactive in identifying emerging issues that may impact product development.
- Submission and follow-up of all regulatory applications to national authority.
- Obtain and maintain necessary regulatory-associated licenses and obligations with national agencies required for the company to conduct its business.
- Support and lead regulatory affairs contribution to product launch activities.
- Obtain, provide and interpret national regulatory intelligence and propose strategic recommendations.
- Comment on draft regulatory guidance/legislation in collaboration with key stakeholders.
- Represent the Regulatory Function at internal and external meetings. Work proactively to build contacts with local Regulatory Authorities and continue to build upon existing network of regulatory contacts.
- Plays an active role in industry organizations building recognition as a thought leader.
- Review and approval of artworks in line with approved licenses and Gilead’s internal processes.
- Liaison with Gilead Sciences Commercial manufacturing regarding introduction of packaging for assigned territory.
- Audit and inspection management support for and follow up of self-inspections, internal inspections and inspections by external relations, i.e Ministry of Health and other bodies by interfacing with key functions (Regulatory Compliance, Quality Assurance)
- Preparation and maintenance of required and relevant local SOPs and associated process documents required internally and externally.
- Training Curricula periodic review and updates.
- Coordination of record retention as required for regulatory affairs.
- Support GDP practices, as required from Regulatory Affairs, e.g. falsified or counterfeit products, recall management etc.
- Contribute to and support the review and approval of promotional materials in accordance to the company’s internal promotion guidelines, national legislation and Code of Practice.
- Provision of guidance and assistance to commercial function during preparation of promotional materials.
- An active member of Turkey Grant and Project Review Committees.
- Partners with Quality to meet local statutory responsibilities and liabilities.
- Support Quality to ensure that a Quality Management System is established and maintained for the product distribution model operating in country.
- Ensure that where Pharmacovigilance responsibilities are assigned to regulatory that these are allocated, supported and delivered appropriately, and as required (e.g. DHPC, risk minimization measures etc.).
Pricing and Reimbursement
- Provide timely regulatory input to External Affairs for agreed pricing and reimbursement strategies. Prepare or oversee the preparation of the required regulatory documentation to support the pricing and reimbursement related applications.
General Management and Administration
- A core and active member of Turkey leadership team.
- Leads and develop the country regulatory team. Sets clear goals and objectives in line with the global/ international RA strategy
- Ensure a sufficiently staffed and adequately trained RA department.
- Leads and / or represent RA within cross-functional and/or cross-regional regulatory sub-teams.
- Plan, monitor, allocate and optimize resources and budget with regards to portfolio evolution as well as regulatory changes.
Specific Education & Experience Requirements:
- Minimum bachelor’s degree in pharmacy, Chemical Engineering, Chemistry, Biology or other related Health/Life Sciences. An advanced degree is desirable.
- A minimum of 12 years’ experience in Regulatory Affairs in the pharmaceutical industry and in particular R@D companies. Min 3-4 years previous people management is also required. - Previous experience in responsibilities already described. - Long standing experience in directly interacting with Regulatory Agencies. - Strong background with dossier submissions.
- Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and across all functions of the organization.
- Demonstrate strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function and in the affiliate.
- Exceptional analytical skills; attention to detail and proven ability to manage multiple tasks and priorities in a matrix team environment.
- Excellent communication, technical and presentation skills.
- Computer skills (Advanced with Microsoft Excel, Word, Outlook and PowerPoint).
- Experience in the registration of Biological or Biotech-based products is advantageous.
Company Core Values
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.