Regulatory Affairs Project Manager

1 week ago

Hsinchu County, Taiwan Synmosa Biopharma Corporation Full time $90,000 - $120,000 per year

Responsibilities:

1.Prepare CTD dossier and responsible for new submission for US, EU and ROW.

2.Review CMC documents, ensuring accuracy, completeness and compliance.

3.Product life cycle maintenance, including variations, renewals, and post-market surveillance report.

4.Cooperate with cross functional teams and manage the project to meet submission goal.

5.Support clinical trial project management and coordinate with CRO.

6.Plan regulatory strategy for global registration.

Experience:

1.Has more than 5+ years RA experience in combination products, e.g. MDI, nasal spray or injection,.

2.Experiences in U.S. and European filing.

3.Experiences in medical device dossier preparation is a plus.

Qualifications:

1.Solid scientific and technical background with excellent communication, interpersonal and organizational skills.

2.Broad knowledge about the FDA or EMA regulatory requirements for drug product and capable of seeking advice and guidance internally and externally as needed.

3.Highly motivated, capable of working independently and also be a good coordinator among cross functional teams.

4.Flexible, hard-working, is capable of managing multiple complex projects at any given time.

5.Excellent planning, time management, presentation, and organization skills.

6.Fluent speaking and writing in English.

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