Open Position At Johnson & Johnson

Johnson & Johnson job Vacancies

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
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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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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.

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How To Submit An Application To Johnson & Johnson For The Open Position

Apply Online Here

 

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