By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description ACCOUNTABILITIES With minimal supervision, plans, executes and manages regulatory submission for assigned compounds in various phases of clinical development, marketing applications, and post -approval life cycle activities. As a RA CMC products leader or member, ensure and/or enhance regulatory compliance with respect to filling requirements for assigned compounds throughout development and the commercial life cycle. · Independently prepare CMC submission dossier, define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement. · With moderate supervision, represent Takeda RA CMC Health Authority meetings and leads or supports CMC preparation activities for meeting with Health Authority on CMC relevant matters, interacts directly with Health Authorities, as required. · With minimal supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval. · With moderate supervision, support Health Authority on-site inspection on CMC RA related matters. · Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in professional and timely manner. · Foster constructive working relationships when interacting with internal or external colleagues. · Evaluates change proposals for regulatory impact. And plans global variations and amendments. Ensure compliance with all applicable Takeda SOPs, and local and international regulations. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: · BS/BA Degree required with 6+ years of relevant Industry, academic or HA experience; advanced degree preferred · Experience with CMC regulatory and regulatory, or equivalent industry experience. · Understanding of scientific principles and regulatory requirements relevant to drug development and post-market support. · Proven ability to provide strategic regulatory guidance to drug development, registration and post market support teams. · Able to deal with issue of critical importance with minimal supervision, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. · Demonstrated emerging leadership, problem-solving ability, flexibility and team work. · Exercises good judgement in elevating and communicating actual or potential issues to line management. · Excellent written and oral communication skills required. · Active participation in Agency/ industry groups/forums preferred. Locations CHN - Shanghai - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

Senior Manager, China CMC Regulatory Affairs.

more at Takeda.

Senior Director, Small Molecule CMC Advisor (Analytical Development)

Key Account Manager

Senior Manager, Lab Operations

similar roles.

Transfer Coordination Specialist (36 Hours)

Senior Patient Access Representative (PRN | As Needed | Shifts Vary | Rotating Holidays & Weekends)

Behavior Specialist - East Bay South

ABA for Children - PAID Training - Alameda

Clayton Homes Home Consultant - Jasper, AL

Pilot Driver