Regulatory Affairs Specialist

• Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective. 

• Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification.

• Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products.

• Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval.

• Responsible for regulatory registration for export products and make sure all the documents are meet the authority’s requirements.

• Responsible for deficiency response preparation to ensure our response meets the authority’s requirements.

• Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.

• Major requirements: Biology, Pharmacy, Medical Technology and Laboratory Science

■ Team Cohesion: Work hard, play hard together!

• Lotus Day
  Our annual corporate day brings the team closer through fun activities, creating unforgettable memories together.

• Yellow Friday
  A monthly event to help you relax amid busy workdays, with diverse activities that strengthen team bonds.

• Clubs & Activities: Extend the fun beyond work
  Join food, travel, cycling, and other clubs to enrich life after work with joy and passion.

• Christmas Party
  A time for employees to gather, with performances and a festive buffet, celebrating friendship and company care in a joyful holiday spirit.

• Diverse CSR Activities
  From beach and mountain cleanups to free medical care in rural areas, dementia care, charity donations, and social support—we actively fulfill our corporate social responsibility.

■ Comprehensive Benefits: Worry-free life, secure future, all-around happiness!

• Generous Bonuses
  Year-end and performance bonuses reward your hard work as the company grows.

• Annual Salary Adjustment
  Opportunities for raises and promotions every year ensure your pay grows with your achievements.

• Special Leave Policy
  Vacation benefits beyond labor law standards, helping you balance work and life.

• Holiday & Birthday Gifts
  Thoughtful cash gifts for Lunar New Year, Dragon Boat Festival, Mid-Autumn Festival, Labor Day, and birthdays bring warm surprises.

• Learning & Development
  From onboarding to advanced training, we provide comprehensive programs—self-management, pharmaceutical expertise, leadership skills—supporting continuous personal and professional growth.

• Volunteer Leave
  Encouraging employees to join public service and give back to society.

■ Extra Allowances

• Wedding gifts, hospitalization and bereavement subsidies, childcare support, travel and sports allowances—all showing we care about your life and health.

■ Employee Insurance: Comprehensive protection
Beyond statutory labor and health insurance, we also provide group insurance to ensure peace of mind every workday.

■ Health First: More than compliance
We offer annual health check-ups exceeding legal requirements, on-site doctor consultations, dedicated occupational health nurses, and wellness seminars.

■ Lotus Culture: Genuine care for every employee
We value open communication through surveys, town halls, roundtables, morning meetings, and sharing sessions. Our international and diverse team lets you experience the richness of a global workplace culture.

■ Friendly Workplace: Balance of work and life
Our Nantou site offers free meals with diverse menus, desserts, fruits, Twinings tea, coffee, rest areas, and cozy nursing rooms—making work more comfortable.

■ Safety & Quality First
We prioritize employee safety and product quality by providing internationally certified GMP protective suits, safety shoes, and protective equipment in a secure working environment.