Ra Compliance Lead Gcc and Nema

6 days ago

مصر, Egypt Johnson & Johnson Full time

Johnson & Johnson is recruiting for a RA Compliance Lead GCC and NEMA, Egypt.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of **Our Credo **. It’s a culture that celebrates **diversity **and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

**Summary of the Job**:
Incumbent will be responsible for Regulatory Compliance for GCC and NEMA LOCs. This may include for example Labelling update, Artwork update, Process optimization, Health Authorities communication and relationships, Change Management, Auditing. In addition, support business collaboration with all stakeholders in order to avoid any supply chain interruption due to Regulatory constraints. This list of responsibilities may vary between clusters and is non-exhaustive; part of this role is also to shape and design the job content of the team in an optimized manner to streamline what can be streamlined and to address the different OpCo needs from RA compliance perspective.

**Duties & Responsibilities**:

- Support from Regulatory, Quality and Compliance standpoint on key projects within GCC and NEMA Regulatory groups such as Process optimization, Health Authorities communication and relationships, Change Management, Archiving and Auditing. Labeling may also be included for some markets.
- Represent RA among key critical stakeholders and project managers within Janssen Supply chain, Global Technical Service (GTS), External Supplier Integration (ESI) and Commercial affiliate GCC (Quality & Regulatory functions), through an End-to-End enterprise approach.
- Issuing and updating Local SOPs and WIs in line with Global SOP and Local Regulation in GCC and NEMA countries.
- Ensure that local activities are done in compliance with national legislation, international regulatory guidelines and internal requirements in collaboration with LOC RA expert team
- Ensure there is a process in place to have continuous training to the regulatory affairs team on internal procedures and systems as needed.
- Generate metrics and compliance reports to monitor and measure regulatory compliance. This includes but not limited to:

- Oversee the process of renewal for Janssen products & manufacturing sites registered in the GCC and NEMA region.
- Oversee the process CMC variations & insert leaflet variations received from Global Regulatory Affairs (GRA).
- Maintain an up-to-date database for all submissions in relevant system and SharePoints.
- Assure Record Management plan for all Regulatory documentation.
- Ensure that the End-to-End labeling management process is in compliance with the local regulation and global SOP. This may vary between clusters.
- Supervise labeling updates and artwork activities to ensure compliance with local regulations and internal procedures.
- Perform impact and applicability assessment on global and regional procedure and reflect in local procedures as applicable.
- Supervise optimization initiatives and remediation activities to ensure business excellence and synergy between LOCs.
- Ensure audit readiness and coordinate audit preparation, during and after audit activities.
- Supervise regulatory affairs projects such as track & trace and eCTD baseline conversion.

**Qualifications**:
**Experience Required**:
**Education**:Bachelor’s degree in pharmacy or equivalent life science degree

**Language**:Fluent in Arabic and English (additional French language is preferred)

**Location**:Cairo - Egypt

**Leadership Behaviors Required**:

- **LIVE OUR CREDO**:Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose
- **CONNECT**:Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player.
- **SHAPE**:Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.
- **Grow**: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes. Awareness of and adherence to Johnson & Johnson Credo values

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into

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