Responsibilities:

1.Handle excipient/API/packaging registrations (DMF/VMF/CEP/ASMF), including document preparation, translation, completeness review, eCTD/eSubmitter formatting, regulatory submissions, and deficiency response.
2.Manage FDA electronic registrations: Drug/Facility Registration, NDC Listing, Self-Identification, Cosmetics Registration, and Medical Device Registration.
3.Oversee domestic/imported API registrations and finished product approvals.
4.Lead generic drug applications for US/EU markets.
5.Provide regulatory consulting services to pharmaceutical partners.

Requirements:

1.Degree in pharmaceuticals, life sciences, or English (with regulatory experience).
2.Strong English proficiency (written/verbal) and communication skills.
3.Diligent, detail-oriented, and fast-learning.
4.Team player with independent problem-solving ability and high EQ.
5.Familiarity with China/US/EU drug regulations.
6.3+ years of regulatory registration experience preferred.

Responsibilities:

1.Conduct independent GMP audits for APIs, finished drugs, and packaging materials, issuing reports in Chinese/English.
2.Perform GMP gap analyses for APIs/drug products and deliver bilingual reports.
3.Review and track CAPA responses.
4.Provide quality system improvement consulting to clients.

Requirements:

1.Pharmaceutical/life sciences background.
2.Fluent English (writing/reading) and communication skills.
3.Proactive learner with teamwork/independent work balance.
4.Expertise in GMP regulations and audit execution.
5.Willingness to travel as needed.
6.5+ years of pharmaceutical industry experience preferred.

Responsibilities:

1.Drive market expansion, promotional campaigns, and sales.
2.Maintain and manage client relationships.
3.Support other business-related initiatives.

Requirements:

1.Outgoing personality with strong communication skills.
2.Bachelor’s degree or above.
3.Adaptability for short-term travel; pharmaceutical experience a plus.
4.Proficient English (written/verbal).