Manager of Regulatory Affairs

vor 3 Wochen

Göttingen, Deutschland Sartorius Vollzeit

Your t asks  

Manage activities of Regulatory Affairs and prepare, review, edit and submit documents to the related authorities

Develop and implement regulatory operating guidelines and common work practices | strategies

Oversee and ensure compliance with regulatory procedures and work practices

Identify an optimal strategy for assigned projects and lead teams in examining regulatory strategy options

Proactively identify new regulations and implement appropriate regulatory strategies accordingly

Interface with (global) regulatory authorities & outside consultants and provide guidance to other regulatory personnel

Train, mentor and supervise regulatory employees, consultants and contractors and develop the team

Provide regulatory advice to multidisciplinary teams as Manager of Regulatory Affairs (x|f|m) 

Your qualifications  

Successfully completed Master's degree in science within a relevant scientific discipline

Many years of professional experience in the medical device industry and | or the biotechnology industry

Deep knowledge in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities

Expertise in the preparation of major regulatory submissions and understanding of applicable regulations

Strong interpersonal skills and the ability to deal effectively with a variety of personnel including as well scientific as manufacturing staff

Strong organizational skills, including the ability to prioritize the own such as direct reports’ workload

Proven ability to work effectively and collaboratively in cross-functional and international teams

Excellent written and verbal communication skills as well in German as in English and willingness to travel (max. %)

Identification with our core values: Sustainability, Openness, Enjoyment and the motivation to work in a fast-growing company

Our Benefits

Life Science & World Health: Social added value through passion for shaping the future of tomorrow 

Open corporate culture: Characterized by diversity, team spirit and progress 

People development opportunities: Training, coaching, leadership programs, etc., on a global level

Mobility benefits : Job ticket as well as car and eBike leasing benefits & free parking garage

Well-Being: Free gym & classes, as well as many health campaigns 

Impressive campus: Open space offices & desk sharing culture as well as open air workplaces 

IT hardware: Newest and powerful Apple products with many new collaboration features for daily business 

Company

Sartorius as a listedcompanywants to simplify progress in the life sciences and biopharmaceutical industry. This enables scientific findings to be translated into new drugs and therapies faster and more efficiently, and gives more people access to better medicine. Nearly , employees at more than production and sales sites worldwide are working towards this vision. Would you also like to contribute to our vision? Grow with us and benefit from the advantages of a global player.​

  • Head of Quality And Regulatory Affairs

    vor 4 Wochen

    Göttingen, Deutschland Aspire Life Sciences Search Vollzeit

    About the jobWe are currently seeking a Head of Quality & Regulatory Affairs BPS (x|f|m) for the Quality System Compliance BPS division for our site in Goettingen, Aubagne or Royston. In this position, you will be a member of the BPS Operations leadership team and will interact closely with the Head of Quality LPS as well as the Quality Management ATS to...

  • Technical Requirements Manager for Systems Transfer

    vor 1 Woche

    Göttingen, Deutschland Qioptiq Photonics GmbH & Co. KG Vollzeit

    Technical Requirements Manager for Systems Transfer (w/m/d) GÖTTINGEN,GERMANY Qioptiq, ein Excelitas Technologies Unternehmen, entwickelt und produziert optische Komponenten und Systeme, die in einer Vielzahl von Anwendungen und Märkten wie z.B. Medizintechnik, Luft- und Raumfahrt sowie Forschung, Entwicklung und der Halbleiterindustrie zum Einsatz...

  • Technical Requirements Manager for Systems Transfer

    vor 2 Monaten

    Göttingen, Deutschland Qioptiq Photonics GmbH & Co. KG Vollzeit

    Technical Requirements Manager for Systems Transfer (w/m/d) GÖTTINGEN,GERMANY Qioptiq, ein Excelitas Technologies Unternehmen, entwickelt und produziert optische Komponenten und Systeme, die in einer Vielzahl von Anwendungen und Märkten wie z.B. Medizintechnik, Luft- und Raumfahrt sowie Forschung, Entwicklung und der Halbleiterindustrie zum Einsatz...

  • Global EHS Manager

    vor 2 Wochen

    Göttingen, Deutschland Novelis Vollzeit

    Overview Who we are Novelis is driven by its purpose to shape a sustainable world together. As a global leader in innovative products and services and the world's largest recycler of aluminum, we partner with customers in the automotive, beverage can, aerospace and specialties industries to deliver solutions that improve the benefits of balanced...

  • CMC Project Manager

    vor 1 Woche

    Göttingen, Niedersachsen, Deutschland NextPharma Vollzeit

    Are you looking for...an exciting professional challenge?We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,200 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working...

  • CMC Project Manager

    vor 3 Wochen

    Göttingen, Niedersachsen, Deutschland NextPharma Vollzeit

    Are you looking for...an exciting professional challenge?We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,200 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working...

  • Manager Global Supply Chain

    vor 3 Wochen

    Göttingen, Deutschland NextPharma Vollzeit

    Manager Global Supply Chain (f/m/d) Location: Tampere, FI ...

  • CMC Project Manager

    vor 1 Woche

    Göttingen, Deutschland NextPharma Remote-Arbeit Freiberufler Vollzeit

    Are you looking for...an exciting professional challenge?We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,200 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working...

  • CMC Project Manager

    vor 2 Wochen

    Göttingen, Deutschland NextPharma Remote-Arbeit Freiberufler Vollzeit

    Are you looking for...an exciting professional challenge?We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,200 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working...

  • Social Media Manager

    vor 2 Wochen

    Göttingen, Göttingen (Kreis), Deutschland Hogrefe Verlag GmbH & Co. KG Vollzeit

    Hogrefe ist eine international tätige, führende Verlagsgruppe im Bereich der Psychologie. Das Verlags­programm umfasst Bücher, Zeitschriften und psychologische Testverfahren in einer Vielzahl von Sprachen. Dazu bieten wir Consulting, Seminare und spezifische elektronische Lösungen an. Am Hauptsitz in Göttingen suchen wir zur Verstärkung des Content...

  • Social Media Manager

    vor 2 Wochen

    Göttingen, Deutschland Hogrefe Verlag GmbH & Co. KG Vollzeit

    Hogrefe ist eine international tätige, führende Verlagsgruppe im Bereich der Psychologie. Das Verlags­programm umfasst Bücher, Zeitschriften und psychologische Testverfahren in einer Vielzahl von Sprachen. Dazu bieten wir Consulting, Seminare und spezifische elektronische Lösungen an. Am Hauptsitz in Göttingen suchen wir zur Verstärkung des Content...

  • Business Process Manager

    vor 1 Monat

    Göttingen, Deutschland KWS Group Vollzeit

    (Junior) Business Process Manager SAP PP/IBP (all gender)Field of Work: ITLocation: Einbeck, Lower Saxony, DELegal Entity: KWS SAAT SE & Co. KGaA (0001)Contract Type: RegularIs Full Time?: YesOnsite/ Remote: Hybrid Working Within CountryJob ID: 14336Do you love to have a lot of freedom in a small team and to have a say in the entire range from project work...

  • Senior Communications Manager

    vor 1 Woche

    Göttingen, Niedersachsen, Deutschland Sartorius Vollzeit

    For our Corporate Communications & Investor Relations department, we are looking for a Senior Communications Manager - Hybrid (x|f|m) for Sartorius Corporate Administration GmbH. In this position, you will act as media spokesperson and be responsible for media relations, in particular for financial and strategic matters of Sartorius AG and Sartorius Stedim...

  • Senior Communications Manager

    vor 4 Wochen

    Göttingen, Niedersachsen, Deutschland Sartorius Vollzeit

    For our Corporate Communications & Investor Relations department, we are looking for a Senior Communications Manager - Hybrid (x|f|m) for Sartorius Corporate Administration GmbH. In this position, you will act as media spokesperson and be responsible for media relations, in particular for financial and strategic matters of Sartorius AG and Sartorius Stedim...

  • Plant Manager/Managing Director

    vor 1 Woche

    Göttingen, Niedersachsen, Deutschland Energy Jobline Vollzeit

    Job DescriptionFresenius Medical Care is the world's leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Fresenius Medical Care has successfully completed its merger with NxStage Medical...

  • Plant Manager/Managing Director

    vor 2 Monaten

    Göttingen, Niedersachsen, Deutschland Energy Jobline Vollzeit

    Job DescriptionFresenius Medical Care is the world's leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Fresenius Medical Care has successfully completed its merger with NxStage Medical...

  • Senior Communications Manager

    vor 4 Wochen

    Göttingen, Deutschland Sartorius Vollzeit

    For our Corporate Communications & Investor Relations department, we are looking for a Senior Communications Manager - Hybrid (x|f|m) for Sartorius Corporate Administration GmbH. In this position, you will act as media spokesperson and be responsible for media relations, in particular for financial and strategic matters of Sartorius AG and Sartorius Stedim...

  • Senior Communications Manager

    vor 1 Woche

    Göttingen, Deutschland Sartorius Vollzeit

    For our Corporate Communications & Investor Relations department, we are looking for a Senior Communications Manager - Hybrid (x|f|m) for Sartorius Corporate Administration GmbH. In this position, you will act as media spokesperson and be responsible for media relations, in particular for financial and strategic matters of Sartorius AG and Sartorius Stedim...

  • Plant Manager/Managing Director

    vor 2 Monaten

    Göttingen, Deutschland Energy Jobline Vollzeit

    Job DescriptionFresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Fresenius Medical Care has successfully completed its merger with NxStage...

  • Software Product Quality Manager SAP

    vor 3 Wochen

    Göttingen, Deutschland NTT DATA Vollzeit

    Software Product Quality Manager SAP (f/m/d) Full or part time (%) You – to break new ground! As NTT DATA Business Solutions, we are more than just a company. We are a team of innovative and passionate people who specialize in creating value-added SAP solutions and guiding our customers on their journey to becoming intelligent...