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Legal, Compliance & Regulatory Affairs

Full time at Danone in Saudi Arabia
Posted on December 24, 2024

Job details

Regional Regulatory & Governmental Affairs Lead

  • Riyadh Plants
  • On-site
Danone MENA is looking for an experienced Regional Regulatory & Governmental Affairs Lead for its Specialized Nutrition (SN) Business in KSA, to be based in Riyadh. This role is responsible for ensuring our SN products comply with regulatory standards across KSA, including end to end management of existing and new product registration. Moreover, the selected candidate will be expected to engage closely with policy & decision makers across KSA, including Ministry of Health & Regulatory Authorities to advocate for faster and more comprehensive access to products. A- Key Accountabilities:
  • Oversee regulatory and technical aspects for all company products ensuring compliance across all operations.
  • Supervise and manage the execution of regulatory filing activities.
  • Develop timely and effective submissions including on-time submissions, follow-up for all registration steps, one-time approvals, management of registrations and product license maintenance activities (variations and renewals).
  • Maintain and monitor the compliance infrastructure within the company to ensure compliance to local country regulations. Deploy an effective compliance training program to the company medical fields staff that will generally enhance the healthcare sector.
  • Collaborate with company principals to facilitate product registration within the region, meeting all local and international standards.
  • Act as a primary liaison between the company and its principals to streamline the registration process.
  • Assist in the process of clearance related to regulatory technical aspects.
  • Coordinate with colleagues within the same General Secretary team to address and resolve technical issues affecting product registration in the region.
  • Liaise with government officials or related stakeholders to exchange information. Prepare deliverables, and lead meetings.
  • Assist senior management and leadership with strategic planning for known and potential regulatory activities related to the business.
  • Collaborate with a group of companies to advocate to areas of common interest.
  • Monitor policy and regulations that could affect the business.
B- Job Dimensions:
  • Building the credibility of our business and brands with key governmental & regulatory authorities/stakeholders.
  • Ensuring our products meet all regulatory standards within the region, and comply with both local & international standards.
  • Strong familiarity with regulatory, governmental & public sector environments, particularly in the field of Nutritional products.
  • Operating within a highly competitive KSA market.

About you

To be successful in the role you should ideally have: Bachelor and Experience:
  • Education: Bachelor’s degree in the field of Medicine/Nutrition/Pharmacy.
  • Experience: 5-7 years of regulatory & governmental affairs experience in the Healthcare or Pharmaceutical Industry.
  • Previous experience in a governmental or public sector role is a plus.
  • Extroverted; with strong networking & communication skills.
  • Only candidates with a valid KSA Iqama will be considered!
  • In-depth knowledge of registration processes & procedures.
  • Strong knowledge of regulatory & governmental affairs.
  • Strong knowledge of healthcare systems in KSA.
Soft Skills:
  • Strong analytical skills.
  • Effective Stakeholder Management.
  • Highly energetic.
Languages required: Proficiency in English and Arabic is a must. Danone Values: Candidates are expected to adhere to Danone's core values: Humanism, Openness, Proximity & Enthusiasm. Mobility: Candidate should preferably be open to moving within the region or outside the region with Danone in 3-4 years if such an opportunity will arise which will contribute to his/her career growth. So, if you are the Regional Regulatory & Governmental Affairs Lead we are looking for, click on "apply" now. #J-18808-Ljbffr

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