Regulatory Affairs Leadership Development Program - EMEA(Job Number: 00000TAR)
Description
The Medical Devices and Diagnostics (MD&D) franchise of Johnson& Johnson is recruiting a Regulatory Affairs Specialist II to join the Regulatory Affairs Leadership Development Program (RALDP). This is a permanent, full-time position with J&J located in EMEA.
Positions are available in UK, Germany, and Dubai.
The Medical Devices and Diagnostics (MD&D) franchises comprise the world's largest medical technology business, providing doctors, nurses, and hospitals with the technologies they need to restore the joys of life to people who suffer from some of the world's most pervasive and chronic conditions.
The Regulatory Affairs Leadership Development Program (RALDP) offers recent Master's graduates a full-time, permanent opportunity with J&J to hit the ground running with responsibilities that can quickly build regulatory affairs skills and leadership capabilities. The RALDP training curriculum is a two year rotational program based on a philosophy of empowering leaders through challenging assignments, clear objectives and feedback, advanced training, and personal coaching. Core competencies and performance is evaluated following each rotation through measurement of clear achievement of business objectives and results. Along with on the job training, the program includes a training curriculum to develop broader regulatory and leadership skills.
The RALDP is a two year program designed to successfully develop future business leaders throughout the MD&D Regulatory organization. Rotations will vary based on location and business need and could include two 12 month rotations or three 8 month rotations. The rotations will be determined by commutable operating company locations.
Under general supervision, the Regulatory Affairs Specialist II provides assistance in preparation and submission of global regulatory documents. This individual coordinates and submits licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The RA Specialist II prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance. Responds to product information requests. Researches and collects information and data to support periodic reports to regulatory agencies. Provides Regulatory Affairs support during internal and external audits. Assists in the development of best practices for Regulatory Affairs processes. Represents Regulatory Affairs on cross-functional project teams.
Qualifications
An Advanced degree in Regulatory Affairs and a minimum of two years of work experience within a regulated industry is required. Candidates with an Advanced degree in Life Science, Engineering, or a related field of study and a minimum of two years of work experience within Regulatory Affairs will also be considered. Candidates must have earned an Advanced degree within the last 24 months to qualify for this program.
Work experience within Regulatory Affairs is preferred. Excellent writing, communication, organizational, and interpersonal skills are required. Experience reviewing documents for assessment of completeness and compliance with regulatory requirements is preferred. Demonstrated ability to effectively coordinate projects and collaborate productively with individuals and departments is required. Experience managing and maintaining documentation for training, operating procedures and/or quality requirements is preferred. Proficiency in the Microsoft Office suite of products is required. Audit experience is an asset. GXP training is an asset.
Positions are available in UK, Germany, and Dubai. Up to approximately 10% domestic travel may be required. Permanent work authorization for the region/country you are applying for is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:Europe/Middle East/Africa-Germany
Other Locations:Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-United Arab Emirates
Organization: Johnson & Johnson (6067)
Job Function: Regulatory Affairs
Description
The Medical Devices and Diagnostics (MD&D) franchise of Johnson& Johnson is recruiting a Regulatory Affairs Specialist II to join the Regulatory Affairs Leadership Development Program (RALDP). This is a permanent, full-time position with J&J located in EMEA.
Positions are available in UK, Germany, and Dubai.
The Medical Devices and Diagnostics (MD&D) franchises comprise the world's largest medical technology business, providing doctors, nurses, and hospitals with the technologies they need to restore the joys of life to people who suffer from some of the world's most pervasive and chronic conditions.
The Regulatory Affairs Leadership Development Program (RALDP) offers recent Master's graduates a full-time, permanent opportunity with J&J to hit the ground running with responsibilities that can quickly build regulatory affairs skills and leadership capabilities. The RALDP training curriculum is a two year rotational program based on a philosophy of empowering leaders through challenging assignments, clear objectives and feedback, advanced training, and personal coaching. Core competencies and performance is evaluated following each rotation through measurement of clear achievement of business objectives and results. Along with on the job training, the program includes a training curriculum to develop broader regulatory and leadership skills.
The RALDP is a two year program designed to successfully develop future business leaders throughout the MD&D Regulatory organization. Rotations will vary based on location and business need and could include two 12 month rotations or three 8 month rotations. The rotations will be determined by commutable operating company locations.
Under general supervision, the Regulatory Affairs Specialist II provides assistance in preparation and submission of global regulatory documents. This individual coordinates and submits licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The RA Specialist II prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance. Responds to product information requests. Researches and collects information and data to support periodic reports to regulatory agencies. Provides Regulatory Affairs support during internal and external audits. Assists in the development of best practices for Regulatory Affairs processes. Represents Regulatory Affairs on cross-functional project teams.
Qualifications
An Advanced degree in Regulatory Affairs and a minimum of two years of work experience within a regulated industry is required. Candidates with an Advanced degree in Life Science, Engineering, or a related field of study and a minimum of two years of work experience within Regulatory Affairs will also be considered. Candidates must have earned an Advanced degree within the last 24 months to qualify for this program.
Work experience within Regulatory Affairs is preferred. Excellent writing, communication, organizational, and interpersonal skills are required. Experience reviewing documents for assessment of completeness and compliance with regulatory requirements is preferred. Demonstrated ability to effectively coordinate projects and collaborate productively with individuals and departments is required. Experience managing and maintaining documentation for training, operating procedures and/or quality requirements is preferred. Proficiency in the Microsoft Office suite of products is required. Audit experience is an asset. GXP training is an asset.
Positions are available in UK, Germany, and Dubai. Up to approximately 10% domestic travel may be required. Permanent work authorization for the region/country you are applying for is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:Europe/Middle East/Africa-Germany
Other Locations:Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-United Arab Emirates
Organization: Johnson & Johnson (6067)
Job Function: Regulatory Affairs