Regulatory Affairs Advisor (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Oberhaching (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 248068BR


Stellenbeschreibung

• Provide regulatory and strategic leadership to assigned biosimilar/biotech project(s)
• Independent and timely preparation/compilation as well as supervision of high quality regulatory documentation during development/product registration/maintenance to support complex global regulatory submissions in various countries (e.g. input to development plan, IMPD, scientific advice briefing books, clinical study protocols…)
• Contribute to and review health authority (HA) responses, as required, to ensure appropriate, consistent and complete answers to any HA questions during development, registration, and product lifecycle
• Provide regulatory and strategic input on clinical study protocols and protocol amendments
• Provide strategic input to the Global Program Team and Regulatory Team on key HA documents, ensuring appropriate line function endorsement
• Direct collaboration with team members and other colleagues from Global Regulatory Affairs Biopharmaceuticals in Schaftenau (Austria)
• 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 fulfill regulatory requirements
• Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs
• Liaison management with regulatory authorities: support coordination of presentations for meetings with regulators and facilitate responses to queries from regulatory authorities, may lead interaction with HAs during key HA meetings
• Responsibility for adherence of expenses to budget (RASB and project related)
• Supervise and prioritize the workload/assignments of Regulatory Managers and Associates
• Conduct annual performance settings, mid-year and end-year reviews, as well as develop people supervised



Research & Development


Mindestanforderungen

• University degree in Natural Sciences, PhD or comparable qualification, alternatively several years of regulatory or other relevant industry experience
• 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 and strategic leadership
• At least 5 years of experience in biotech regulatory affairs
• Must have proven leadership skills and supervisor experience
• Successful direct and indirect leadership in order to strengthen und retain talent pipeline
• Fluent English required (oral and written)

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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