Director Regulatory Affairs Emerging Markets
vor 1 Woche
THE POSITION:
This role of is the senior most regulatory role within EPD in the Emerging Market business unit_.
_As a leader, the role of the Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to support and partner the business by ensuring the successful development, manufacture and distribution of products in accordance with relevant legislations.
The incumbent will also be responsible for the overall development and supervision of a large team of regulatory professionals. The individual will have division level influence.The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide senior management with regulatory metrics and actionable intelligence.
Primary Function & Major Responsibilities:
REGULATORY AFFAIRS
- Lead Regulatory Strategic planning leveraging domain expertise, understanding of the external regulatory landscape, industry trends, internal capabilities in alignment with business priorities.
- Develop & guide Regulatory Strategy by combining knowledge of scientific, regulatory and business issues to develop products to meet required global, regional and local legislations
- Lead advocacy with scientific / academic institutions to promote Abbott science with key opinion leaders in collaboration with product development and other expert functions.
- Develop and lead external stakeholder engagement strategy to proactively shape regulatory landscape in alignment with business strategy
- Ensure compliance with local, regional, global polices
- Lead, guide and develop regulatory staff (direct reports) and also Regional / Affiliate staff in a matrix environment. Develop organization for future fit capabilities.
- Be the nodal person from Regulatory for coordinating Innovation and Development activities in EM regions
- Liaise with regulatory, medical, clinical and other functions to create and implement successful tailormade product development strategies suited to local needs.
- Accountable for ensuring adherence to timelines for EM innovation projects and creation of 'approval ready' dossiers.
- Single Point of Contact at EM level for all I&D projects in EM markets.
- For codevelopment projects in EM regions, be the interface on behalf of Abbott for development and submission activities.
- Responsible for providing updates to EM as well as I&D management on progress of projects.
- Responsible for review of clinical, preclinical and regulatory data, and making recommendations to management on GO/NOGO decisions at key development checkpoints.
- Be the SPoC from EM for MAGIC, EM-IB and EIB for EMinnovation projects.
_ LEADERSHIP_
- _ Manage complexity/pace of business (e.g., globalization, pace of change, priorities versus resources, execution of internal restructuring)_
- _ Represent the global organization to regulatory agencies and regulatory agencies to the organization ensuring both internal and external credibility_
- _ Represent the business as the key functional leader and establish organizational culture, such as promoting core Abbott values_
- _ Accountable for regulatory decisions made, such as strategy and submission content, to obtain optimal success with agency _
- _Establish core capabilities/skills to support changing regulatory environment (e.g., new/changing regulations) _
- _Expand approach toward a global perspective to understand different culture/businesses/regulatory systems and the impact on our products and markets _
- _Set goals for the business that are agreed upon and supported by all functional areas to advance the business_
- _ Leverage regulatory as a strategy to provide a competitive advantage for driving the business (e.g., profitability, reputation) that benefits the end user _
- _Drive change and execute business strategy while finding business solutions to meet regulatory requirements_
- _ Promote environment of innovation, risk management and focus on the customer while balancing cultural, financial and resource constraints_
- _ Set example utilizing creative problem-solving techniques to make calculated risk-based decisions in a timely manner_
- _ Achieve strategic balance in a tactical environment and influence global regulatory environment_
- _ Maintain positive relationships internally and externally_
- _ Learn from others and look to proactively discover methods to improve the business_
- _ Right-size infrastructure to support business growth by improving the integration of new business and divestiture of existing products and businesses_
**_
TALENT MANAGEMENT_**- _ Attract and retain talent, ensure development (leadership, cross-functional, cross-divisional, technical, global perspective) and diversity while facing increasing demands, and while maintaining efficiencies and effectiveness_
- _ Select and develop future leaders with global regulatory experience using assignments that are cross functional or d
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