REGULATORY AFFAIRS PROJECT MANAGER
Vor 5 Tagen
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
As Regulatory Affairs Project Manager, you will be responsible for managing various projects for Alira Health clients with the support of Senior regulatory experts and subject matter experts within Alira Health. You will have the opportunity to support clients in a broad range of drug development activities from early to late stage of development, to address client issues and to achieve project objectives.
We are looking for an experienced candidate with strong agility and organizational skills, the ability to prioritize and influence teams, as well as developing client relationships.
You will work in a global environment with close collaboration with other regulatory consultants and other Alira Health departments such as medical strategy, CMC, biometrics, market access, business development both in the US and in Europe and/or directly with the experts from the clients.
You will manage your own regulatory activities and support the regulatory team in their activities to ensure timely delivery of high-quality documents and best regulatory strategy to meet business needs of our clients. In addition to your consultancy responsibilities, you will have the opportunity to contribute to the shaping of the regulatory department to make it best in class by providing your experience in the field of consultancy, biotech and/or pharmaceutical industry.
Job Description
ESSENTIAL JOB FUNCTIONS
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Develop and lead regulatory activities for their own projects with support of Alira Senior Director/SVP if needed e.g.:
- Provide regulatory strategy advice for entry to human, clinical development or registration.
- Prepare Health Authorities interaction in collaboration with other functions.
- Prepare and submit packages for regulatory agencies e.g. EMA, EU National Health Authorities, FDA for different activities like CTA/IND, scientific advice, Orphan drug designation.
- Conduct gap analyses, product classification, regulatory roadmap.
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Be in contact with clients and advise them to develop regulatory proposals based on their business needs.
- Develop business proposals, assess and organize regulatory activities to be executed for projects.
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Manage the project such that it is completed within budget, schedule and according to contract specifications.
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Contribute to the development of the regulatory practice.
- Develop webinars or white papers to promote Alira Health.
- Develop internal best practices or ways of working to increase the quality and efficiency of the department.
EXPERIENCE
- 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology).
- At least 6-8 years' regulatory affairs experience either in regulatory affairs consulting or in pharmaceutical industry or in biotech company.
DEMONSTRATED CAPABILITIES
- Expertise in early development program including gap analyses, EU scientific advice (national and EMA); US FDA meetings, preparation & submitting clinical trials application.
- Experience in NDA/BLA/MAA, IND/CTA.
- Experience in orphan drug designation, pediatric procedure.
- Experienced in small molecules/biologicals. Expertise in radioligand or ATMP will be a plus.
- Excellent verbal and written English communication and writing skills (knowledge of second language would be an asset).
- Organizational skills and regulatory project management skills, ability to successfully manage multiple projects to deadlines.
- Committed to continuous improvement.
Languages
Education
Contract Type: Regular
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