Senior Regional Regulatory Affairs Manager Middle East

Dubai, United Arab Emirates

Job Description

RegulatoryStrategy:
  • Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectives
Management of Regulatory Team/operations in the assigned territories:
  • Lead the assigned team, build priority projects into team’s My Impact Plans, identify resource gaps, make priority calls, propose solutions, including outsourcing.
  • Management of assigned regulatory projects (base and development projects) including planning and managing regulatory activities on both new and in-line products in accordance with the regulations and company policies.
  • Develop registration strategies and lead the registration process for all products (medicine, health products, food supplements, medical devices, cosmetics…etc) in scope in the assigned territories.
  • Ensure regulatory compliance of registered products, promotional material, and related commercial initiatives.
  • Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements and internal policies and procedures including but not limited to advertising, packaging communications, and import procedures.
  • Ensure regulatory input to project teams and stakeholders.
  • Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or insights that will impact P&G Personal Healthcare business, and communicate regulatory risk assessment to the appropriate local and global functions.
  • Deliver team capability, coach, and develop team members, own career development & compensation, determine priorities, set the work, and ensures technical rigor for team members.
  • As applicable: Actively support hiring into upcoming vacancies in line with P&G requirements and ensure smooth onboarding for new employees.
  • Ensure Regulatory budget is delivered. Manage the expenses as per budget planning of the team. Deliver on cluster/regional productivity targets.
External Affairs:
  • Interface with relevant government agencies, industry associations and key opinion leaders to assess the impact and implementation of required compliance initiatives to meet all regulations, laws and industry best practices that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.
  • Interface and represent company interests with relevant government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines.
Collaboration with Multifunctional Teams / Regulatory Leadership
  • Act as business partner and Co-partner with other Function Leaders.
  • Day to day collaboration with Multifunction teams and Leadership teams for projects and deliverables.
  • Contribute to strategic decisions requiring regulatory input to minimize risks and ensure maintenance of the product portfolio. Ensure portfolio is risk assessed and conduct gap analyses on dossiers to deliver compliance on an ongoing basis.
  • Provide advice and training on regulatory compliance to the different stakeholders.

Qualifications

  • Sound Regulatory knowledge and understanding on Middle East markets for medicinal products, Food supplements, Medical devices, Cosmetic, Advertisement regulations, E.com. Consumer Health products experience is a plus.
  • Overall experience in Regulatory Affairs of 10-12 years and “preferably”, a minimum of 3-5 years of people management experience
  • Bachelors / master’s degree in pharmacy / medicines/allied science streams Arabic Speaking.
  • Requires depth of expertise in own specialized discipline or field combined with knowledge of the market and competitors.
Job locations:
Dubai, Dubai, United Arab Emirates Job Type: Full time Job categories: Research And Development Req No: R000061311

Beware of fraud agents! do not pay money to get a job

MNCJobsGulf.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Job Detail

  • Job Id
    JD1437337
  • 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