Regulatory Affairs Lead

**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.