Regulatory Affairs GPH Team Lead at Johnson & Johnson

Position Details

• We are currently recruiting for a Regulatory Affairs Team Lead for their GPH RA team. In this role, you will develop and lead GPH Regulatory Affairs activities, strategy, operations, and compliance activities in African countries' Markets.
• You will act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding portfolio for small molecules. You will be responsible as liaison and main contact between LOCs and international groups (Therapeutic Areas teams, CMC teams, Labelling teams, and Regulatory Quality teams).
• Next to this, you will provide regulatory support for tenders and support daily business and product supply in accordance with J&J guidelines and local laws & regulations as well as ensure optimal compliance to local, regional, and Janssen regulations, to minimize risk for the patient and Janssen business.

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.

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.

Compliance Responsibilities:

• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
• Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors.

Daily Business & Product Supply Support:

• Support Ad Hoc requests and ensure interactions with Heath authorities
• Provide regulatory support to all company functions upon request.

Other Features of the Job:

• Keeps overview of all TA specific activities:
• Monitoring implementation of procedures.

Education & Qualifications

• Minimum of 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.