Job Vacancies

Open Position At Johnson & Johnson

There is a new Open Position At Johnson & Johnson. The company is looking to hire a Regulatory Affairs GPH Expert. In this role, you will develop and lead GPH Regulatory Affairs activities, strategy, operations, and compliance activities in African countries’ Markets.

Essential duties and responsibilities:

Act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding Portfolio of Small molecules

Provide strategic and valuable RA input into CVT and Value excellence teams.
Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.

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Ensure new products registration

Execute regulatory plans and manage timelines to achieve the stated goals.
Coordinate the preparation, review, submission, and follow‐up of regulatory files that are properly formatted and in compliance with local regulations in the markets.
Track and follow‐up with local marketing authorization holder/distributor submission of regulatory files (including but not limited to: variations, response to questions) to local Health Authorities and ensure that filing and submission meet local requirements and company objectives.

Maintenance and follow‐up of marketed products:

Coordinate the preparation, review, submission and follow‐up of the product’s life cycle management in compliance with local regulations and Internal procedures.
Distribute/share official notifications and HA information with internal stakeholders as applicable.
Ensure close follow-up with partners to ensure timely submission and reporting

Liaison and main contact between LOC and international & external stakeholders

Keep EMRL informed of regulatory status in LOCs and forward to them requests and relevant information from LOCs.
Keep a timely and transparent communication flow of critical priorities and decisions. And keep alignment across different stakeholders in timely manner.
Key external participation in Industry groups with structured approach to share within internal teams
Supervise the team and ensure alignment on strategy and timelines commitments

Maintain archiving and appropriate databases and systems:

Ensure electronic and paper tracking of regulatory activities Marketing authorizations and lifecycle management via appropriate systems
Populate and update appropriate J&J databases as per J&J processes.
Update, maintain and use regulatory databases, tracking tables, and information systems.

Candidate profile:

Education & qualifications

Minimum a Bachelor’s Degree‐ scientific/ pharmacist with initial experience in Regulatory Affairs. Ideally, you have a Master’s Degree within the scope of Regulatory Affairs.

Knowledge & Abilities

Good knowledge of regulatory requirements, local Health Authority regulations & guidelines, as well as regulations from other countries.
Good level of English
Knowledge, understanding and interpretation of legislation

Skills

Excellent communication and presentation skills, both verbal and written
Ability to manage multiple assignments
Awareness and ability to understand the broader picture of compliance and launch time
Strong interpersonal skills to deal with sensitive and occasionally contentious issues.