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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 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 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
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 eg. EMA, EU National Health Authorities, FDA for different activities like CTA/IND, scientific advice, Orphan drug designation,
Conduct gap analyses, product classification, regulatory roadmap
Be in contact with clients and advice them to develop regulatory proposal based on their business needs
Develop business proposal, assess and organize regulatory activities to be executed for projects
Manage the project such that it is completed within budget, schedule and according to contract specifications
Contribute to the development of the regulatory practice
Develop webinar or white paper 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
RegularOther Jobs from Alira Health
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Senior Clinical Research Associate
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Senior Clinical Research Associate
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