Multidisciplinary Expert Network with VC-Backed Track Record

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Senior professional with extensive experience in clinical development and operations across pharmaceutical, biotech, and CRO settings. 

She has contributed to the design and execution of global clinical programs, with a focus on rare diseases and advanced therapies.

Over the years, she has led multidisciplinary teams, managed external partners, and supported regulatory and compliance activities at both regional and global levels. 

Her background includes strategic planning, oversight of clinical trial operations, and participation in regulatory interactions with major authorities.

With a strong commitment to mentoring and organizational development, she brings a collaborative and pragmatic approach to complex clinical challenges.

Senior professional with a BS in Pharmaceutical Biotechnology, an MS in Biology, and 15+ years of experience in pharmaceutical companies, primarily in Regulatory Affairs (both big pharma and start-ups).

She drives the regulatory function to support both the scientific and business goals of the company, translating objectives into the most appropriate regulatory strategies to achieve worldwide registration of innovative and biotech products. She works cross-functionally with multiple departments to design optimal development, regulatory, and launch plans from the early stages of the product journey (Phase 1 through Phase 3).

Through extensive interactions with major health authorities worldwide, she has gained a deep understanding of the importance of establishing transparent, mutually beneficial relationships. She appreciates how different cultures, regulations, and markets must be considered when designing a new product plan.

She has strengthened her leadership skills and expertise by leading a global team distributed across the USA, China, and Europe.

 A senior professional with 15+ years of experience across pharmaceutical, biotech, and CRO settings, she combines deep expertise in clinical development and regulatory affairs with solid knowledge of CMC and quality aspects.

She has supported global programs in rare diseases and advanced therapies, working cross-functionally to align regulatory strategy, clinical operations, and manufacturing requirements.

She is experienced in interactions with major health authorities, submission planning, and managing compliance throughout the product lifecycle.

She brings a pragmatic mindset, strong leadership, and a collaborative approach to tackling complex development challenges.