Regulatory Affairs Lead MISSA - Medical Devices Job

Job description

Regulatory Affairs Lead MISSA
- Medical Devices-000010ARDescriptionJohnson & JohnsonCaring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace research and science
- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.Our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Johnson & Johnson Middle east covers 3 sectors: Consumer, Medical Devices and Diagnostics and Pharma. Generally covers Middle East, North Africa & Pakistan region, 37 countries; 300 employees across MENAP, with 37 Nationalities.
In order to streamline the complexity of the current MISSA (Maghreb, Iran, Sub
- Saharan Africa) business model and consolidate the management and order-to-cash processes within one location, J&J MISSA operations is moving from Kirkton Campus in Scotland and the Shared Customer Service center in Paris to J&J Middle East office in Dubai.
Purpose of the positionCoordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.
Responsibilities
- Responsible for Marketing authorization Application Submission at health authorities in MISSA countries, communication with local distributors (regulatory department) and Authorities for final approval of license.
- Active role in interpretation of queries raised by authorities.
Product maintenance – Variations & Renewal
- Requesting registration documents required to approve variations and license renewal at MOHs, compiling, submission and follow up for final approval.
- Active role in interpretation of queries and letters of deficiency raised by authoritiesTender Support
- Request, compile and submit the registration documentation required for tenders and customs clearance on time coordinating with business leads, Marketing,
- Franchise RA and Supply chain to define strategy, approach and provide technical expertise that support Company products over competition.
Cooperation with Supply chain
- Collaboration and update SC on product changes (e.g. shelf life, specifications, source country and packaging materials), update on approval status to ensure only compliant products supplied to markets.
- Updating the logistic department with the regulatory issues that may affect on the product dispatch and clearance in countries.
Copy review
- Reviewing & signing off promotional materials according to J&J procedure .
- Interaction with Authorities
- Managing good working relationship with authorities, involved in regulatory review and decision, in MISSA countries.
- To ensure that the company’s regulatory and statutory requirements are met.
- Ensure timely notification of complaint, vigilance, field safety corrective action and recall activities to relevant authorities.
Regulatory intelligence – Legislation
- Scan the external environment and do lobbying activities e.g. liaising with other local market-based colleagues (e.g Industry group) to facilitate the review and approval of regulatory submissions.
- Providing regulatory and legislation insights and better interpretation about MDs regulations change and potential impact on business to local business leads and CEO lead.
- Work with EMEA Regulatory Regional, thus ensuring local needs are considered in Global / Regional regulatory strategies which support the strategic planning process, local inputs to dossier developmentQualificationsEducation & Qualifications
- Bachelor or Master DegreeExperience, skills and competencies
- Spoken English and French is a must
- Excellent communication skills
- Strong organizational and time management skills with an ability to work under pressure.
- Capable to persuade and influence at the highest level
- Possesses a Global mindset with an ability to make decisions based on broad standards; follows global trends and assesses local impact; develops global networks and demonstrates horizontal leadership.
- Finds innovative solutions to business problems, and right from the concept stage provides the regulatory route(s) to a solution.
- Experience in Regulatory either in Pharmaceuticals and/or Medical Devices. Any regulatory experience in Consumer will also be considered.
Primary Location:Europe/Middle East/Africa-United Arab Emirates-Dubai-DubaiOrganization: Johnson & Johnson Middle East FZ-LLC (8608)Job Function: Regulatory Affairs