Regulatory Affairs Specialist MISSA - Egypt

Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people
of Johnson & Johnson for over ‎125 years. We embrace research and science -
bringing innovative ideas, products, and services to advance the health and
well-being of people. Employees of the Johnson & Johnson Family of Companies
work with partners in health care to touch the lives of over a billion people
every day, throughout the world.
With $‎70.1 billion in ‎2015 sales, Johnson & Johnson is the world's most
comprehensive and broadly based manufacturer of health care products, as well
as a provider of related services, for the consumer, pharmaceutical, and
medical devices, and diagnostics markets. There are more than ‎265 Johnson &
Johnson operating companies employing approximately ‎126,500 people and with
products touching the lives of over a billion people every day, throughout the
world.
Thriving on a diverse company culture, celebrating the uniqueness of our
employees and committed to inclusion. Proud to be an equal opportunity
employer. And our culture is interconnected by the shared values of Our
Credo. It 's a culture that celebrates diversity and diverse
perspectives. It helps employees achieve an effective mix between work and
home life and supports their efforts to have a positive impact on their
communities.

Sector/Organization Overview

Johnson & Johnson Medtech

Summary of the job:

MISSA is of strategic focus for the company, it is characterized by the
rapidly evolving and complex Regulatory Environment, the aim of this role is
to manage all aspects of regulatory activities for the region of Maghreb, Sub
Sahara Africa and IRAN including but not limited to: dossier preparation for
new product registration, Renewals, changes submission and follow up, respond
to tender requests, copy review, customs clearance and reportability of
adverse events.
Work efficiently with external and internal stakeholder to provide required
regulatory input to achieve regulatory goals and objectives and overall
company goals.

Duties & Responsibilities

• Ensures compliance with local countries rules and regulations by compiling registration dossiers in line with country requirements ensures submission follow up on application till approval.


• On time submission of re-registration applications and product variations


• Ensures that the license for distribution of medical devices is maintained / updated appropriately.


• Provides the necessary regulatory support for importation requests.


• Ensures proper maintenance of product documentation and local Regulatory document database


• Leads efficient and constructive communication with internal and external stakeholder (cross function - Franchise - distributors)


• Responds to tender requests within the communicated timelines


• Responsible for copy review and approval in line with internal JnJ standards


• Responds to Franchise RA requests related to the regulation and registration requirements in the region.


• Efficient communication with internal and external stakeholders


• Works in compliance with the current SOPs and should be able to update the same according to business need.


• Understand the regulatory environment of the region and keep all relevant stakeholders updated with the new guidelines and regulation impacting the business and registration timelines.


• Assesses the impact of the various changes that a product may undergo during its life cycle and implements the actions necessary to maintain registration in the target countries.


• Assesses and decides whether or not Materiovigilance incidents are reportable and reports and follows up with local authorities if needed.
  Main performance measures (Performance Goals)


• Project Management, planning, execution and follow up.


• Business Plan support in term of Registration and providing the regulatory support to ensure business continuity and no business interruption due to regulatory reasons.


• Monitoring and shaping the external regulatory environment, especially distributors and Health Authorities


• Working closely with regional RA team, commercial and market to support business plan and strategic goals for the region.


• Execute the Regulatory strategy defined by the global/regional leaders.

Qualifications

Experience Required

• Education: Medical/Scientific/Pharmaceutical Background


• Years of Experience: ‎3-‎6 in Regulatory Affairs medical devices is a must have


• Experience in multinational medical devices company is prefered


• Language: English, Arabic is a must and French (optional)


• Location: Egypt

Leadership Behaviors Required

• LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo.


• CONNECT: Develop deep insights into the needs of our patients, customers, markets, and communities.


• SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally.


• LEAD: Create an environment where leadership and talent development is top priority.


• DELIVER : Deliver results by inspiring and mobilizing people and teams.

Technical/Functional Skills Required

• Regulatory Affairs


• English, Arabic is a must and French (optional)


• Medical/Scientific/Pharmaceutical Background.


• Big picture orientation and strategic thinking


• Able to manage complexities.


• Conflict solving.


• Multitasking.

Leadership Profile Required

• Big Picture orientation.


• Good communication skill


• Time management


• Self-motivated


• Problem solving


• Attention to details.


• Sense of urgency


• Planning


• Growth mindset
  For more than ‎130 years, diversity, equity & inclusion (DEI) have been part of
  our cultural fabric at Johnson & Johnson and woven into how we do business
  every day. Our commitment to respect the dignity and diversity of all is
  embedded in our Credo.
  We know that the success of our business depends on having the best talent in
  a workforce that reflects the diverse markets we serve around the world and an
  inclusive culture that values different perspectives and life experiences
  That is why we in KSA are working to create an inclusive environment where
  diverse backgrounds, perspectives and experiences are valued and each and
  every one of our people feel that they belong and can reach their potential.
  No matter who they are.
  Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!