Team Leader Regulatory Affairs (m/w)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Oberhaching (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 241280BR


Stellenbeschreibung

• Independent and timely preparation/compilation as well as supervision of high quality regulatory documentation during development and product registration to support complex global regulatory submissions (e.g. input to development plan, IMPD, scientific advice briefing books, clinical study protocols)
• Preparation/coordination of CTD for submission according to regulatory requirements of different HRM regions
• Liaise with Regulatory Authorities
• Prepare responses to health authority questions during development, registration and product lifecycle respecting agreed regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Develop, lead and influence internal and external cross functional teams to ensure the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner to support regulatory requirements
• Directly work with team members and colleagues from the Global Regulatory Affairs Biopharmaceuticals team in Kundl/Schaftenau (Austria)
• Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs
• Keep knowledge up to date with regard to guidelines and regulatory as well as technical trends
• Supervise and prioritize the workload/assignments of regulatory managers and associates to assure compliance with regulatory agency regulations and timely submissions to support team objectives
• Conduct annual performance settings, mid-year and end-year reviews, as well as develop people supervised
• Training of people
• Responsibility to ensure working compliance with the applicable SOPs, GOPs and WIs
• Responsibility for adherence of expenses to budget



Research & Development


Mindestanforderungen

• University degree in natural sciences, PhD or comparable qualification
• Fluent English required (oral and written)
• German knowledge desirable
• Good understanding of the regulatory requirements for filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance
• Ability to construct persuasive scientific documents to support/defend regulatory strategies and registrations
• Proven track record of agency interactions
• At least 5 years of experience in Biotech Regulatory Affairs
• Must have proven leadership skills and supervisor experience
• Willingness to travel



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