Job Description - Regulatory Affairs Specialist (2506232582W)
Position Summary
As a Regulatory Affairs Specialist, you will join a diverse team and be responsible for regulatory and compliance activities at the Schaffhausen site and drive various compliance and business improvements projects.
Due to the high number of ongoing projects combined with daily business activities, we are looking for a colleague who quickly can support the team with a focus on coordination of regulatory requests, health authorities communication and processes.
Responsibilities:
* Support of Regulatory Affairs Coordination in all areas, supporting the registration of pharmaceutical products in the export markets with documents that are either created internally, ordered from authorities or from partner companies (e.g. GMP certificates, manufacturing licenses, Certificates of Pharmaceutical Products)
* Processing inquiries from Health Authorities and J&J Regulatory Affairs
* Coordination of documents and communication with Local Operating Companies or to Regulatory Affairs worldwide
* Direct contact with Health Authorities regarding GMP documents
* Participation, as regulatory representative, in strategic projects for the site
* Coordinates, compiles, and manages Regulatory country specific documents required as part of the approval process for global submissions
* Coordinates the update of Site-specific documents (e.g. Site Master File, Major Changes lists, etc…)
* Supports Change Control strategy and management on site (participates in pre-CC meetings, supports Annual Report creation, reviews changes from regulatory perspective, etc…)
* Acts as a liaison between the global regulatory organization and business units in Schaffhausen
* Improve regulatory knowledge on site (organizing trainings, developing job aids, etc…)
* Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.
Qualifications:
* You have a Bachelor’s or Master’s Degree in a technical or science field
* You have proven experience (minimum 3 yrs) in a GMP regulated Pharma production environment, or experience in a relevant Regulatory, Compliance or Quality role (minimum 2 yrs)
* PREVIOUS EXPERIENCE IN PHARMACEUTICAL OR MEDICAL DEVICES PREFERABLE
* Strong attention to detail with high-level verbal and written communication skills, team-player, works efficiently in cross-functional and cross-company teams
* DEMONSTRATED ABILITY TO UNDERSTAND PRIORITIES
* You are used to working in a GMP-environment, and have a genuine quality mindset which is shown in your daily work
* YOU HAVE EXPERIENCE AS TEAM OR PROJECT LEAD
* You have English (mandatory) and German (preferable)
If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.
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