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Regulatory Manager – Ankara, Global Regulatory Affairs (GRA)
Regulatory Manager- Ankara, Global Regulatory Affairs (GRA) - Regulatory Affiliate is accountable to support establishing the local regulatory strategy and plan for assigned product(s) in country, ensure local plan aligns to the global regulatory strategy and ensure local regulations and region/country business needs are included.
The Manager is accountable to provide regulatory expertise in the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s), and foster an environment of operational excellence in collaboration with cross-functional teams and provide influence to the local regulatory authority to successfully achieve regulatory objectives.
The Manager is also responsible for Regulatory Policy and HA Relations and maintains the Regulatory activities at Ankara office
Primary Responsibilities
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 affiliate's 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.
- Develop the regulatory plan.
- Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan.
- Represent the Regulatory Affairs function in New Product Planning discussions.
- Interact directly, or facilitate interactions with, regulatory bodies with effective communication and negotiation ensuring impactful influence.
- Voicing affiliate needs and perspectives to global and regional regulatory contacts.
- Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
- Represent Lilly in industry association meetings and workstreams related to regulatory strategy and harmonization.
- Regulatory intelligence - gather relevant information from local and global regulatory environments with potential local impact and for competitive advantage.
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.
- Lead regulatory audits and inspections in collaboration with Regulatory Quality Organization.
- Lead and coordinate implementation of corrective/preventive actions.
- Lead regulatory quality oversight for external parties.
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.
In addition to the above, the Manager may have the below responsibilities:
- Perform the function of Primary ALRP.
Process Improvement
- Identify local process improvement opportunities and ensure implementation of relevant global regulatory initiatives.
- Effectively participate in affiliate cross-functional teams and provide regulatory status updates, input and knowledge.
- Ensure alignment and implementation of launch readiness initiatives.
- Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives to improve and maintain understanding of regulatory affairs within affiliate leadership.
MoH Relations
- Facilitate and maintain relationships with key regulatory officials (External Influence).
- Secure appointments in according to the KPIs set for the Regulatory Authority visits & defined affiliate regulatory needs.
- Collaborate with the Affiliate cross functional teams to secure timely submissions & approvals to TITCK including the commercial, medical and quality submissions.
- Monitor Lilly's performance versus the market and develop product-specific and general strategies to improve outcomes.
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.
- Create and maintain positive/effective working environment.
- Present at external regulatory meetings, workshops and conferences to develop/sustain professional expertise.
- Support the Regulatory Affairs Director in developing a comprehensive influencing strategy that will define and represent the affiliate's position on specific regulatory issues and outline recommended action plans for interactions with regulators.
Minimum Qualification Requirements
- Bachelor's degree in pharmacy
- At least 8 years industry related experience in regulatory affairs.
- 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
- Understand the internal business complexities, and the mutual impact between regulatory and other functions, and ability to demonstrate the added value of regulatory in the business.
Other Information/Additional Preferences
- 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
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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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