Manager:in Arzneimittelzulassung - Baden-Württemberg, Deutschland - SciPro

Beschreibung

Regulatory Affairs Manager - DACH (m/f/x) | Baden – Württemberg Area | Pharmaceutical Industry

Are you a regulatory affairs specialist with a knack for navigating the intricacies of marketing authorizations within a global context? Do you excel in adhering to eCTD/eSubmission standards and thrive on contributing to regulatory strategy development? If you're seeking an opportunity to make a significant impact at a well-established medium-sized pharmaceutical company with international reach, your search ends here

Key Responsibilities:

• care of all local RA activities and deliverables within the D-A-CH countries, including regulatory support for AAA Pharma.
• responsible for DE/AT/CH exclusive licenses (i.e. maintenance, submissions, texts)
• responsible for initial creation and maintenance of product information texts in German language
• and organization of new and updated product registration application dossiers related to the submission procedure, MAH transfers, renewals and variation procedures in DACH
• of content and regulatory quality especially for the administrative documentation (Module 1)
• for the complete maintenance and lifecycle management activities of the exclusive licenses in DACH
• with other teams/departments in regulatory affairs relevant projects and assessment of regulatory questions
• update, correction and submission of regulatory documentation after receiving the documents from the respective department for the exclusive licenses in DACH
• in regulatory affairs related projects regarding developing of new products and supporting TTs for the exclusive licenses in DACH
• updating of legislation requirements in DACH region.
• knowledge of the technical & regulatory requirements and experience regarding the registration & life cycle management (inter alia tech/site transfers, product information changes, product optimization etc.) of medicinal products with special focus on EU and the D-A-CH countries.
• least a basic understanding for the regulatory requirements for food supplements in EU/D-A-CH.
• approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of ensuring registrations / variations are successfully approved.
• tracking and prioritization of daily business tasks.

Qualifications:

• or master's degree in pharmacy, (veterinary) medicine, or related natural sciences.
• a Master's in Drug Regulatory Affairs.
• years of regulatory affairs experience in the pharmaceutical industry or food supplements sector.
• understanding of registration and lifecycle management activities.
• experience in negotiating and communicating with regulatory authorities.
• in Regulatory Information Management Systems & Databases.
• project management skills.
• reliability, teamwork, initiative, cross-functional collaboration, and multitasking abilities.
• written and verbal English; proficiency in German and other languages is advantageous.

Benefits:

• salary package inclusive of base salary and 13th-month salary.
• employment contract.
• annual leave entitlement of 30 days.
• part-time working arrangement (up to 25 hours per week).
• accessibility via public transport and ample parking availability.
• start date with the option for up to 40-60% remote work.

Interested in this Opportunity?

If you're eager to leverage your expertise in regulatory affairs within a dynamic pharmaceutical environment, we encourage you to submit your application today We're also open to considering applications for alternative positions within our organization.

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We eagerly await your application