Senior Regulatory Affairs Associate

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Cairo, Egypt

Job Description:

Essential Job Duties and Responsibilities:

• Handling Marketing Authorization applications, life cycle maintenance activities, relevant labelling updates and ensure that filing & submission meet local requirements & company objectives.

• Coordinate the preparation, review, submission and follow-up of regulatory files that are properly formatted and in compliance with local regulations.

• Be involved in all aspects of the application to take the product to market.

• Execute regulatory plans and manage timelines to achieve the stated goals.

• Respond to inquiries from the different HAs.

• Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities.

• Strategic alignment on the preliminary submission of new products with the global team & internal stakeholders.

• Develop & maintain relationships with Health Authorities & other relevant organizations.

• Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines.

• Alignment with the different stakeholders ex.supply chain, marketing,commercial ,market access,…etc

• Coordinate and execute submission of products label updates.

• Responsible for updating the database and support Janssen systems.

• Comply with J&J guidelines and local laws & regulations.

• Handling RA activities (Renewal, Label updates, Registration analysis or any other RA activities)

Minimum Qualification

• Minimally basic degree in Pharmacy.

• Min 5 years of Regulatory experience & working in MNCs .

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Handling RA activities (Renewal, Label updates, Registration analysis or any other RA activities)

• Demonstrated ability to manage multiple assignments.

• Desire to work as part of an effective, cohesive group.