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.
View: New Open Role At Deloitte
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.
See Also: Career Opening At fairafric Ghana Ltd
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.
Recommended: Ghana SCHOLSEC & French Government Scholarships 2023
How To Submit An Application To Johnson & Johnson For The Open Position
WhatsApp Job & Scholarship Alert
- To get daily Job and Scholarship Alerts on Whatsapp, Join Our WhatsApp Group via the link below.
NOTE: PLEASE IF YOU’RE ON ANY OF OUR WHATSAPP GROUPS, DON’T JOIN THIS ONE
CLICK HERE TO JOIN WHATSAPP GROUP
UNDER NO CIRCUMSTANCE SHOULD AN APPLICANT PAY MONEY TO ANYONE IN GETTING A JOB WE HAVE PUBLISHED