Regulatory Affairs Lead

7 months ago


Riyadh, Saudi Arabia Johnson & Johnson Full time

**About Johnson & Johnson**:
For our Local Operating Company in Saudi Arabia, we are currently recruiting for a Regulatory Affairs Expert to be based in our Riyadh office. In this role you will be leading our Regulatory activities across the region, as well as support a team based across the KSA and Gulf cluster. This role is an excellent opportunity for experienced RA professionals with desire to mentor a strong team of experts in the region.

**Principal Activities**:
**Lead the regulatory activities for the TA across the KSA and Gulf clusters**:
You are responsible for the oversight of the regulatory activities related to TA across the region such as submissions/approval of new MAAs, Renewals, LCM and other RA activities. Besides this, you will lead the TA Regulatory team while ensuring providing the needed guidance and support for the team efficient performance and development.

**Regulatory TA Cluster Lead while supporting RA TA Team for the both clusters**:

- Provide strategic and Business RA input to BU and Value excellence teams.
- Understand Business model and strategy drivers.
- Cooperation and partnership horizontally with commercial, MAF and other functions (Govern. Affairs, CQ, Human Resources, Logistics, SC ), as well as vertically with IBVTs and Brand Teams to craft the local strategy and made valuable contributions.
- Explore and drive innovative acceleration pathways for regulatory submissions/approvals to support local/regional commercial opportunities.
- Continue to strengthen the unique value proposition of our portfolio through project accelerations, expansion and Life Cycle Management.
- Act as regulatory representative on project and provide advice/inputs on specific projects contributing to the development of project plans and target product profiles.

**Optimizing Cross-functional collaboration**:

- Ensure active representation of the regulatory department as key partner within the CVT with continuous engagement and support.
- Building a continuous communication process with other functions on LOC and regional level.
- Lead/participate in strategic and operational regulatory projects for portfolio optimization aiming to improve the internal processes and collaboration with other internal stakeholders.

**Compliance Responsibilities**:

- Ensure safety reporting requirements as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors

**Line Management Responsibilities**:
Advance career development through an integrated talent planning and management cycle that enables a targeted and pro-active approach to attract, develop, and retain a diverse and inclusive team with a deep focus on GRA’s technical, scientific, and leadership capabilities.

**Qualifications**:
**Required skills**:

- Pharmacist or Scientific Degree with total experience no less than 8 years in the field.
- Solid understanding of regulatory requirements, HA regulations & guidelines in GCC countries
- Demonstrated ability to manage multiple assignments
- Anticipation and planning skills
- Highly organized with efficient time management
- Ability to work cross functionally.
- Ability to lead and coach
- Good level in English and Arabic

Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



  • Riyadh, Saudi Arabia Alcon Full time

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...


  • Riyadh, Saudi Arabia Al Safa Pharmaceutical Store Full time

    **Regulatory Affairs Manager**: - **Job Summary** Tasks and Responsibilities - contributing to the organization’s strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters; - writing and periodically updating drug regulatory affairs (DRA)-related local SOPs; - reviewing draft registration files and...


  • Riyadh, Saudi Arabia Hikma Pharmaceuticals PLC Full time

    To coordinate regulatory activities throughout the regulatory life cycle by carrying out project specific tasks related to writing and collecting submission documents from cross functional departments to ensure an efficient preparation of submissions that comply with latest regulations and within the defined timelines. **Description**: Follows all relevant...


  • Riyadh, Saudi Arabia Almarai Full time

    Regulatory Affairs Supervisor| Riyadh, Saudi Arabia **The Company**: An aggressive expansion program together with acquisitions in new vertical markets have created an exciting opportunity to join a dynamic multinational team dedicated to furthering growth plans for the group. **About the Role**: The Regulatory Affairs Supervisor is responsible to...


  • Riyadh, Saudi Arabia IBM Full time

    Introduction At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most...


  • Riyadh, Saudi Arabia Boston Scientific Corporation Full time

    **Regulatory Affairs Specialist, KSA**: - Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...


  • Riyadh, Saudi Arabia Kinetic Full time

    **Kinetic** has partnered with a multinational **Pharmaceutical** company who are hiring a **Regulatory Affairs Officer** to be based in **Riyadh**.** *** **_Please note that due to Saudization, only Saudi Nationals can be considered for this role._** *** **The main responsibilities will include but not limited to**: - Track and follow up with the...


  • Riyadh, Saudi Arabia Kinetic Full time

    **Kinetic** has partnered with a leading **Pharmaceutical** company who are hiring a **Deputy Regulatory Affairs Manager** to be based in **Riyadh**.** **Key aspects of the role include**: - Develop and implement regulatory strategies to ensure timely and successful product registrations and approvals. - Prepare, and execute regulatory operational plans...


  • Riyadh, Saudi Arabia Dexcom Full time

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...


  • Riyadh, Saudi Arabia Haleon Full time

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep...


  • Riyadh, Saudi Arabia Philips Full time

    **Job Title**: Regulatory Affairs Manager, Hospital Patient Monitoring META **Job title**: Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals. **You are responsible for** - Create regulatory awareness level as determined within the organization. - Supports implementation of simplified yet...

  • Regulatory Affairs

    6 months ago


    Riyadh, Saudi Arabia Radiometer Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • Riyadh, Saudi Arabia Cepheid Full time

    **In this role, the associate**: - Identify information sources and resources for local regulations. - Serve as RA lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global regions outside US and EU to ensure OTD product launches. - Be...


  • Riyadh, Saudi Arabia Danone Full time

    About the job Danone MENA is looking for a talented **Regulatory affairs executive** to be based in **Riyadh, Saudi Arabia**, like you! In the context of Specialized Nutrition MENA, you will be responsible for managing regulatory submissions within the pharmaceutical industry. This involves preparing and submitting documents to regulatory Manager, ensuring...


  • Riyadh, Saudi Arabia Biogen Full time

    **Job Description** Purpose**: The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, International Growth markets (IGM), Development, Chemistry, Manufacturing and Control (CMC) Regional contacts as well as relevant global, regional and local stakeholders. He/she will lead local regulatory activities in KSA to...


  • Riyadh, Saudi Arabia Microsoft Full time

    Microsoft’s mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can...


  • Riyadh, Saudi Arabia Jamjoom pharma Full time

    Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the...

  • Reg Affairs

    6 months ago


    Riyadh, Saudi Arabia Boston Scientific Corporation Full time

    **Reg Affairs - P4**: - Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees,...


  • Riyadh, Saudi Arabia Amgen Full time

    **Regional Specific Activities** - Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements. - Contribute to and execute the filing plan for their country where applicable - Review source text for country labeling - Review promotion and non-promotion materials - Disseminate relevant information to team(s)...


  • Riyadh, Saudi Arabia Al Safi-Danone Co.Ltd. Full time

    **Role Purpose**: To validate artworks and product advertisements and ensure they follow the SFDA and GSO standards and to keep quality certificates updated as required. **Key Accountabilities**: - Lead the process of validation artworks (Marketing, R&D &Agency) - Reviewing and validating product artwork from Quality, Regulatory and R&D perspective -...