Regulatory Affairs Specialist

Dubai, United Arab Emirates

Job Description

Descriptionrecruiting for:Regulatory Affairs SpecialistThis position reports into Head of Regulatory Affairs Middle East and is based in Dubai, UAE.Who We AreAt Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA\xc2\xae, AVEENO\xc2\xae, TYLENOL\xc2\xae, LISTERINE\xc2\xae, JOHNSON's\xc2\xae and BAND-AID\xc2\xae that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .What You Will DoThe Regulatory Affairs Manager is responsible for execution of Regulatory activities across products, cosmetics, Consumer Healthcare, and medical devices to meet Business/Regulatory requirements for Kenvue.Key Responsibilities
  • Handle activities at a departmental level on both short- and long-term department and company objectives.
  • Work autonomously, but in alignment with direct manager, to oversee Regulatory Affairs activities for specific area(s) of responsibility.
  • Manage activities at a departmental level on both short and long term department and company objectives.
  • Understands the regulatory landscape in the middle east. Monitors the regulatory environment and provides assessment of the impact of new and changing regulations on the company's areas of interest.
  • Manages the coordination, compilation and submission of regulatory submissions (through distributors and also through online governmental registration portals, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements.
  • Reviews (where relevant) and approves artwork, where relevant, and promotional material to ensure regulatory compliance for submissions.
  • Reviews product Master Texts and oversee/support with all the EN-AR translations (where relevant).
  • Monitors and progress of applications against set timelines, taking action, where necessary, to minimize delays and anticipate difficulties/challenges.
  • Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
  • May provide risk assessments on competitive claims balancing business needs and risks to be challenged by authorities. Provides assessments and data to execute plans to address sensitive issues.
  • To be a proactive and credible business partner to Regulatory Affairs and in-market and/or Regional Business colleagues. To manage 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.
  • Manages the Regulatory team's financials, through raising Purchase Orders and tracking all the spending of the entire team in accordance to the Regulatory and R&D cost centers.
What We Are Looking ForRequired Qualifications
  • Education: Life Science Degree or equivalent qualification with a major in pharmaceuticals
  • Years of Experience: 6 Years Pharmaceutical/Regulatory Experience
  • Language: Arabic/English
  • Location: Dubai, UAE.
Desired Qualifications
  • Experience from a multi-national or regional company is required
  • Experience in Pharma Medicine and Cosmetics & Personal Care products
  • In depth knowledge of GCC regulation.
  • Excellent Oral & written communication skills, in English and Arabic.
  • Should have strong analytical problem solving and interpersonal skills, leadership, influencing, and presentation skills.
  • Ability to work under pressure achieving consistently high results through individual and team efforts.
  • Build and develop networks and strong working relationships with internal & external customers
What's In It For You
  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
  • Learning & Development Opportunities
  • Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Job Detail

  • Job Id
    JD1695928
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Dubai, United Arab Emirates
  • Education
    Not mentioned