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J&J Family of Companies Regulatory Affairs Specialist EMEA (m/f/d) in Ettlingen, Germany

Johnson & Johnson is the world´s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services. The values that guide our decision making are motivated by a culture of caring. Caring for the world ... one person at a time? Inspires and unites the people of Johnson & Johnson. The company is operating in the fields of pharmaceuticals, medical devices and consumer health care products with 128,000 employees in more than 250 companies around the world. In Germany the Johnson & Johnson GmbH represents the consumer health care business. With a broad portfolio of well-known brands we are in touch with the consumer at every stage of life.

Johnson & Johnson Vision AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages.

To support our Team in Ettlingen, we are currently looking for a Regulatory Affairs Specialist EMEA (m/f/d)

  • Prepare, create and review of product labelling according to RA requirements and internal labelling process for the EMEA region.

  • Support technical documents preparation and the collection of all the necessary documentation required for registration dossiers, license maintenance or any other competent authority requirement in EMEA countries, accordingly to respective country-specific requirements.

  • Assist in regulatory projects, track processes incl. timely entries in regulatory databases and systems as well as compliant document archiving for projects assigned.

  • Communicate with internal and external partners to support regulatory affairs projects.

  • Participates in compliance activities and responds to moderately complex compliance queries.

  • Provides regulatory support across all functional areas involved in projects and as liaison between all departments within the company.

  • Support business targets associated with the EMEA product labeling compliance.

Qualifikationen

  • Minimum education required for competent performance:

  • University degree in life sciences (pharmacy, chemistry, biology or related discipline) or in Business, Graphic Arts, Marketing, Advertising, or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the required job.

  • Very good English skills (more languages are of advantage)

  • Proficiency of standard software (Word, Excel, Outlook, Power Point)

  • Strong attention to detail and quality

  • Experience of performing design control and document proof reading

  • Ability to act in multicultural and cross functional environment essential

  • Proficient knowledge of Adobe software’s like “Photoshop”, “Indesign” & “Illustrator”.

  • Good interpersonal and communication skills.

    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 Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every 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”!

    Severely disabled applicants will be given special consideration if they are equally qualified.

Primärer Standort

Deutschland-Baden Württemberg-Ettlingen-

Andere Standorte

Deutschland-Baden Württemberg-Ettlingen

Organisation

AMO Germany GmbH (7137)

Funktion

Regulatory Affairs

Requisition ID

2206077515W

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