February 3rd, 2023 at 07:34 am
Job Opportunity at Johnson & Johnson
Job Title: Regulatory Affairs GPH Expert
The GPH RA team at Johnson & Johnson NEMA is looking for a Regulatory Affairs Team Lead right now. In this job, you will come up with and lead the strategy, operations, and compliance activities for GPH Regulatory Affairs in the markets of African countries.
You will be a member of the Regulatory Cluster Value Team (RA CVT) and a RA Expert for the small molecules portfolio. Then, You will be the main person LOCs and international groups talk to and work with (Therapeutic Areas teams, CMC teams, Labelling teams, and Regulatory Quality teams).
You will also provide regulatory support for tenders and support daily business and product supply in line with J&J guidelines and local laws and regulations. You will also make sure that local, regional, and Janssen regulations are followed as best as possible to minimize risk for both patients and the Janssen business.
Essential duties and responsibilities:
Act as a member of the Regulatory Cluster Value Team (RA CVT) and as an RA Expert for the Small molecules Portfolio.
- Give the CVT and Value excellence teams strategic and useful information from RA.
- Serve as the regulatory representative on project teams and give advice on specific projects to help create project plans and profiles for the products they want to sell.
Make sure to register new products.
- Execute regulatory plans and keep track of deadlines to reach the goals set out
- Coordinate the making, reviewing, sending, and following up on regulatory files that are in the right format and follow the rules in each market
- Track and follow up with local marketing authorization holder/distributor submission of regulatory files (including, but not limited to, changes, responses to questions) to local Health Authorities and make sure that filing and submission meet local requirements and company goals.
Maintenance and follow-up of products that have been sold:
- Coordiante la preparación, revisión, presentación y seguimiento de la gestión del ciclo de vida del producto, de acuerdo con las regl
- Share official notices and information about HA with internal stakeholders as needed.
- Follow up closely with partners to make sure that submissions and reports are made on time.
Liaison between LOC and international and external stakeholders and the main point of contact
- Keep EMRL updated on the regulatory situation in LOCs and send them requests and other important information from LOCs.
- Keep a clear and timely flow of information about important priorities and decisions. And keep everyone on the same page as quickly as possible.
- Key external participation in industry groups with a structured way to share with internal teams
- Watch over the team and make sure everyone agrees on the strategy and deadlines.
Keep records and the right databases and systems in place:
- Track regulatory activities both online and on paper. Authorizations for marketing and lifecycle management through the right systems
- Fill out and update the right J&J databases based on how J&J works.
- Keep regulatory databases, tracking tables, and information systems up to date and use them.
Compliance Responsibilities
- Make sure safety reporting requirements (timely AE/PQC reporting) set out in company policies and SOPs (Standard Operating Procedures) are met and, where necessary, properly managed when planning projects, making materials, carrying out projects, and hiring vendors.
- Make sure that HCC and legal requirements (such as Fair Market Value, Transfer of Value rules, and Promotional Materials rules) are fully understood, managed, and followed when planning projects, making materials, putting projects into action, and hiring vendors.
- Help with daily business and product supply
- Help with ad hoc requests and make sure you talk to health officials.
- When asked, give regulatory support to all company functions.
Other things about the job:
- Keeps track of all activities related to the TA:
- Keeping an eye on how things are done
Qualifications
Scientist or pharmacist with at least a Bachelor’s degree and some experience in Regulatory Affairs. You should have a Master’s degree in Regulatory Affairs, if possible.
Knowledge and skills
- Good knowledge of regulatory requirements, rules and guidelines from the local Health Authority, as well as rules from other countries.
- Good level of English Knowledge of, and ability to understand and explain, the law
- Excellent verbal and written communication and presentation skills. Able to handle multiple assignments.
- Awareness and the ability to see how compliance and launch time fit into the bigger picture
- Strong people skills are needed to deal with sensitive and sometimes controversial issues.
How to Apply for this Job Opportunity at Johnson & Johnson
Deadline: February 7, 2023
Also, For more Job Opportunities CLICK HERE
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