Manager Regulatory Affairs* Business Unit Pharma

55122 Mainz (Stadt), 55116 Mainz
12.04.2021

Daten dieser Anzeige

Job-ID: 021199651
Manager Regulatory Affairs* Business Unit Pharma

SCHOTT AG

Germany

https://schott-ag.contactrh.com/jobs/4348/35063683/en_US?utm_campaign=jobware&utm_source=jobware&utm_medium=jobware

As Manager Regulatory Affairs, you are responsible for negotiating regulatory aspects for product registrations and regulatory issues with agents and consultants worldwide. Moreover, you coordinate the resulting measures for product registrations in cooperation with local agents. In your role, You are advisor and trainer for internal BU-P-specific regulatory topics, such as national product registrations or Drug Master Files (DMF's) You implement standards and central specifications for the DMF structure of the BU P locations in consultation, as well as monitor the DMF's of the sites and ensure their compliance You issue response documents to official enquiries, as well as statements/LoA's for product registrations You identify and define regulatory requirements for primary packaging systems and Medical Devices You are responsible for the availability and review of required standards, international pharmacopoeias and guidelines You evaluate and provide necessary software tools as well as adjust processes together with IT to increase efficiency in regulatory activities You support the harmonization of the BU-P quality management system in the regulatory area

International technology group o specialty glasses and glass-ceramics o more than 130 years experience o 16,500 employees in around 34 countries o innovative ideas for the world of tomorrow Be the ONE whose ideas help saving lives. Manager Regulatory Affairs* Business Unit Pharma Because human health matters: Join a team where your visions, your creativity and our mutual collaboration can make a difference contributing to something as meaningful as saving lives. At SCHOTT Pharma (P), we design solutions to ensure medicines are safe and easy to use for people around the world. Today, we play an essential role in delivering a COVID-19 vaccine to hospitals and patients. You perform best in an inclusive environment that is based on mutual trust and respect among each other. You are a strong communicator - clear, concise, and persuasive in style always having the best solution for our products and thus customers in mind. You look for a role with a great deal of influence in a highly successful company.  Then you are right with us! Be our Manager Regulatory Affairs* for our Business Unit Pharmaceutical Systems at the SCHOTT headquarter in Germany, Mainz.    Your Tasks As Manager Regulatory Affairs, you are responsible for negotiating regulatory aspects for product registrations and regulatory issues with agents and consultants worldwide. Moreover, you coordinate the resulting measures for product registrations in cooperation with local agents. In your role, You are advisor and trainer for internal BU-P-specific regulatory topics, such as national product registrations or Drug Master Files (DMF's) You implement standards and central specifications for the DMF structure of the BU P locations in consultation, as well as monitor the DMF's of the sites and ensure their compliance You issue response documents to official enquiries, as well as statements/LoA's for product registrations You identify and define regulatory requirements for primary packaging systems and Medical Devices  You are responsible for the availability and review of required standards, international pharmacopoeias and guidelines You evaluate and provide necessary software tools as well as adjust processes together with IT to increase efficiency in regulatory activities You support the harmonization of the BU-P quality management system in the regulatory area Your Profile You have a university degree in Science (biotechnology, pharmacy, pharmaceutical technology), PhD is preferred. You have 5-10 years of professional experience in regulatory affairs / medical devices with interfaces to quality management. It is mandatory that you have profound knowledge of the regulatory framework for parenteral packaging, combination products and medical devices.  Experience of regulatory and medical device business in Asia is beneficial. You are a proactive team player and have already worked with your structured working methods in international teams. You display precise communication skills by abstracting and explaining complex data in simplified illustrations with your business fluent English language skills; German is a plus. Your Benefits SCHOTT is a leading international technology group in the areas of specialty glass, glass-ceramics and related high-tech materials as well as in the field of parenteral packaging for the pharmaceutical industry with over 130 years of experience. We foster a unique company culture that emphasizes authenticity, diversity and inclusivity, because we know: Motivated and committed employees are the cornerstone of our success.   As a Corporate Foundation with a research mission, we feel responsible to focus on the wellbeing of our employees. We support your professional growth through systematic personnel development. We work together to design your personal career path without losing focus on the balance between work and family, your health and well-being and flexible work schedules. Our benefits program offers you a brought range of interesting options. Sounds right for you? Then get in touch and let's make a difference together:   SCHOTT AG, Human Resources, Cornelia Kempkes *profile and personality matter to us - gender, identity or origin don´t. Apply now

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Kunststoff/ Keramik/ Glas

Angestellter/ Fachkraft

Vollzeit

55122 Mainz (Stadt)

55116 Mainz