Senior Regulatory Affairs Associate Johnson and Johnson

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.