BE - Senior RA Program Lead

Based in the European HQ in Belgium, as Senior RA Program, you will lead, develop and implements regulatory strategies and processes to assure timely global commercialization of CSS products in compliance with applicable European regulations and international standards.

Your responsibilities and your Impact:

• Provides strategic guidance to CSS related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines

• Serves as an EU regulatory SME for the portfolio under his/ her responsibility, supporting daily RA activities

• Provides advice, counsel and expertise on RA issues, both proactively and reactively, to project teams

• Partners closely with internal partners across Johnson & Johnson (including Legal Manufacturers, Importers, Distributors, Marketing, R&D, Regional Regulatory Affairs, Quality Clinical and Medical Affairs) to ensure that the stakeholders' voices are evaluated within strategies for product launches and product modifications

• Develops and sustains relationships with RA affiliates as their primary point of contact, contributing to the development and execution of local registration strategy. This includes planning, prioritization and preparation of responses to regulatory agencies' questions and other correspondence for new registrations, product modifications and renewals

• Liaises with the manufacturer to obtain all necessary documents and prepares international documentation to support product registration internationally

• Facilitates discussions between EU based external manufacturers and CSS franchises to support projects in addition to obtaining regulatory documents to support global product registrations

• Provides regulatory support for Supply Chain initiatives for CSS

• Drive CSS input for enterprise regulatory projects

• Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables

• Writes, reviews and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements

• Creates and approves Engineering Change Orders pertaining to the Senior RA Program Lead’s projects and duties (including but not limited to SOPs, EU labeling approval)

• Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with applicable regulations (Copy Review Process)

• Primary Point of Contact for the distribution controls of medical devices in accordance their regulatory requirements and registration status & support associated processes and system development

• Primary Point of Contact for customization activities in the European Distribution Center assuring compliance to global market requirements & support associated processes and system development

• Supports announced and unannounced inspections by Competent Authorities and internal functions

• Represents CSS in various internal and external forums for the Franchise

• Responsible for communicating business related issues or opportunities to next management level

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Is a critical partner for the CSS International Execution team in the EMEA region

Experience Required for Role

Essential:

• University degree in Science, Engineering, Technical or Biomedical field or Law (or equivalent degree with adequate experience)

• 6-8 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries

• Good knowledge of medical device regulatory requirements in the EU

• Ability to work effectively in a highly matrixed organization

• Project Management Skills

• Ability to proactively identify new ideas and solutions

• Strong communication, influencing and presentation skills

• A strong results-orientation and sense of urgency

• Skilled in establishing partnerships with regional and Franchise colleagues

• Excellent written and verbal communications skills in English (required)

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that we do not accept applications via email).

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.