There is a new Open slot 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.
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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
- 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.
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How To Submit An Application To Johnson & Johnson For The Open Slot
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