Regulatory Affairs Senior Specialist

Job Description

Johnson & Johnson Services, Inc. is recruiting for a Regulatory Affairs Senior Specialist to be located in Dubai, UAE. Caring for the world, one person at a time has encouraged and united the people of Johnson & Johnson for over 125 years. We adopt 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 worlds 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. Growing 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 Regulatory Affairs, Johnson & Johnson Consumer healthcare Summary of the job: Execute Regulatory activities across AMET products, cosmetics, Consumer Healthcare, and medical devices to meet Business/Regulatory requirements for the Johnson &Johnson Consumer Family of Companies. Duties & Responsibilities Work autonomously, but in alignment with local manager, to coordinate day-to-day Regulatory Affairs activities for specific area(s) of responsibility. Handle activities at a departmental level on both short- and long-term department and company objectives. Works autonomously in Agility squad forms maintaining agility concepts for Customer / Consumer Obsession, empowerment, Cross-Functional collaboration, Bold prioritization and Test & Learn methodology. Understands the regulatory landscape across Africa Middle East and Turkey. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the companys areas of interest. Handles compliance within the department by ensuring global, regional, and local processes, policies, Sops and working instructions are in place and adhered to. Handles the coordination, compilation and submission of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements as per our Regulatory Standard Management SOPs. Develops, translates, reviews (where relevant) and approves Labeling, artwork, where relevant, and promotional materials to ensure regulatory compliance for submissions. Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges. Leads, monitors, assesses and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management Interacts with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters. Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. To handle external contractors and consultants to ensure that appropriate standards and timelines are met. Works with strategic direction and performs with a high degree of independent judgment and execution which directly impacts the operational results of the business unit. Management of admin support for e-Market Place Purchasing controls. Follow Good Documentation and Data Integrity Practices in accordance with cGMP in J&J systems as CEDMS , RegPoint ..etc. Good Regulatory Practice: To ensure the maintenance of accurate records (archives) of regulatory activities and registrations documentation, as appropriate. Assists in the development of standard methodologies for Regulatory Affairs processes To develop networks and strong working relationships with regulatory agencies and industry bodies: Liaise with regulatory agency personnel. Liaise with Regulatory Affairs personnel at local distributors to influence results Build and maintain excellent relationships with relevant regulatory bodies, external bodies, contractors and corporate partners which will have direct impact on Regulatory function. Build and develop networks and strong working relationships with internal customers: To provide general regulatory advice. To provide regular updates, reports & Metrics. To specifically develop strong working relationships with Regional & Global RA, Regulatory contacts and LOC business partners Qualifications Experience Required Education: Life Science Degree or equivalent qualification with a major in pharmaceuticals Years of Experience: 5 Years Pharmaceutical/Regulatory Experience. Experience in Mergers/Acquisitions. Experience in Project Managements (MAHs, Sources & Labeling Changes). Language:Arabic/English Location:Dubai-UAE Technical/Functional Skills Required Experience from a multi-national or regional company is required Experience in Pharma Medicine and Cosmetics & Personal Care products In depth knowledge of MENAP and European legislation. Excellent Oral & written communication skills Team activity. Collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental results Build and maintain external manufacturer relationships to ensure alignment on business needs and partnership to drive responsiveness and reliability to deliver product which meets all quality requirements and customer service metrics. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health?s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. Leadership Behaviors Required LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose CONNECT: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player. SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change. Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes. 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 the UAE 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?! Primary Location United Arab Emirates-Dubai-Dubai- Organization Johnson & Johnson Middle East FZ-LLC (8608) Job Function Regulatory Affairs Requisition ID 2206020484W

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