Regulatory Affairs Process

2 weeks ago

مصر, Egypt Johnson & Johnson Full time

**Position Summary**:
In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping healthcare in the region. This polyvalent role offers strong collaboration between different groups across the company.

**Main responsibilities**:
**In charge of the Regulatory Affairs **Process **& **Compliance activities**:

- Stay up to date with evolving regulations and standards in the Pharma sector in the NEMA region and ensure that J&J remains in compliance.
- Prepare for and assist during regulatory audits and inspections, providing accurate and comprehensive information.
- Collaborate with the Commercial Quality team to maintain and improve quality management systems and procedures.
- Work closely with functions that might have interdependencies with Regulatory Affairs (e.g. Pharmacovigilance, Quality, Supply Chain, Labeling..) to improve collaboration and outcomes/deliverables
- Assist in product registrations, submissions, and approvals, ensuring timely compliance with regulatory requirements and J&J’s procedures.
- Conduct risk assessments and develop strategies to mitigate regulatory risks and issues.
- Ensure efficient implementation and maintenance of the key RA processes and corresponding systems, including but not limited to Change controls, local deviations, CAPAs, records management, and archiving. Planning & tracking, information sharing, and Regulatory Intelligence.
- Provide regulatory process support for Regulatory Experts to ensure they recognize procedures they should adhere to.
- Write and review Job Aids, Work Instructions, and SOPs in accordance with the applicable responsibilities' scope.

**QUALIFICATIONS**:
**Job Requirements**:
**Qualification & Experience**:

- Scientific Degree or equivalent experience, within Pharmaceutical or Biomedical Science.
- proven experience (5+ years) in RA Compliance, Regulatory Affairs, and Quality

**Knowledge & Skills**:

- Proficiency in English and Arabic, and knowledge of French is preferred
- Project Management experience
- Experience in the use of a selection of the following technologies: Information systems based on database technology or Web/Internet technology, document management systems
- Cross-Functional work

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.

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