The Director EMEA Regulatory Affairs Lifecycle Innovation (RALI) is rresponsible for managing and directing a team to create and execute the strategy for obtaining product registrations and supporting the lifecycle management of MD products from across multiple business units in approximately 72 countries including direct management of Regulatory Affairs teams in these countries (includes Egypt, MISSA, Levant, South Africa, Pakistan & 5 Central Eastern Europe countries)
Responsibilities
Develop and implement country objectives based on MD business priorities, and global regulatory strategies and plans in support of Medical Device business regulatory imperatives
Coordinate with other Regional RALI leaders to develop and harmonize efficient processes for creating technical documentation required to register new products in markets
Align with Regional organization on accountabilities and interfaces to create the country-specific regulatory strategy for registering new products and existing products
Provide leadership and manage relationships through extensive interdependent partnering, benchmarking, leveraging of best practices, and forming strategic alliances with cross functional partners to drive key business goals and objectives
Developing and aligning project priorities across multiple business units through collaboration with internal RA partners and other functional business partners
Provide support for Supply Chain and Compliance initiatives that impact the portfolio of marketed products (e.g., cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements)
In partnership with the RALI BU and Regional leadership will develop plans and coordinate regulatory submissions to support product registrations and maintenance
Collaborates with the RALI leadership team in establishing short and long term strategic goals and directs implementation to achieve objectives
Plans and directs resources and activities of regulatory group to deliver business imperatives , maintain product regulatory compliance. and sustain market access
Drives effective business strategies to ensure regulatory programs and projects are standardized to obtain earliest possible approvals.
Provides measurable input into the development and implementation of Regulatory Affairs processes, standards, or plans in support of the organisation’s strategies.
Drives a culture of Business Process Excellence in partnership with the RALI leadership.
Provides overall management of the Regulatory staff development and budget to support business objectives.
Establishes learning initiatives and training of country personnel on current and emerging regulatory and related requirements
Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures
In partnership with MD RA Regional Policy leadership ensure appropriate Outreach and Shaping through involvement in local trade associations and building relationships with local regulatory authorities
Serve and primary liaison to Region and be an active participant on the Regional RA leadership team
Requirements
A minimum of a Bachelor’s degree or equivalent.
Minimum of 8-10 years’ experience in a regulated industry required. Medical device industry preferred
Experience should include conducting regulatory activities that achieved foreign regulatory approval of medical devices or pharmaceutical products.
English/Arabic language skills are required; French is optional
Working knowledge of regulatory requirements in Middle East & other assigned countries and ability to translate regulations into clear data requirements to support registrations.
Strong experience working with regulatory environments outside of the US and EU including experience with global regulators is desirable.
Ability to interpret policy changes and assess the impact on countries in collaboration with MD RA Policy and Intelligence team and other senior leaders is required.
Must be able to articulate country regulatory requirements to multiple audiences including senior business leadership.
Supervisory and talent development experience is required.
Excellent communication skills and ability to build and maintain relationships at all levels in the organization and with external customers and Regulatory.
Highly skilled in establishing partnerships with regional colleagues, successfully influence functional leaders and able to work collaboratively in a highly matrix environment.
Exercises a high level of judgement, strategic thinking and execution anticipating, interpreting, evaluating and resolving complex organisational opportunities whilst appreciating the direct impact on the operational results of the business.
Decisions impact portfolio and help shape long-term strategies.
Strong process improvement skills along with a strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously in an expansive, changing environment.
Available to travel (30%-50%) - Location of the job could be Dubai or Cairo
Primary Location: Europe/Middle East/Africa-United Arab Emirates-Dubai-Dubai
Organization: Johnson & Johnson Middle East Inc (8605)
Travel: Yes, 50 % of the Time
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