Associate Manager, Regulatory Affairs (Contract) - Austria
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
An exciting opportunity has arisen to join the Austrian Regulatory Affairs team based in Vienna for a maternity contract of 12 months as Regulatory Affairs Manager
Essential Duties and Job Functions:
- Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations).
- Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
- Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
- May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
- Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
- Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
- Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
- Excellent organization skills and ability to work on a number of projects with tight timelines is required.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.
- Work is performed under minimal direction of a senior Regulatory Affairs professional.
Knowledge, Experience and Skills:
- Excellent Knowledge of the German language
- Excellent oral and written English communications skills and ability to work both within the group and across cross functional groups.
- Demonstrated effectiveness in cooperation and teamwork with judgment/problem solving and analytical and assessment skills.
- Planning and information seeking skills and ability to work independently.
- Problem solving, strategic thinking skills with ability to impact and influence
- Attention to detail with accuracy and quality
- Ability to understand and effectively relate to external and internal customers.
- Business awareness and professionalism