Covance Senior Associate Regulatory Submission in Tokyo, Japan

Job Overview

Looking to start your career? Want to be part of a global leader in Clinical Services? Come join our Clinical Development Services operations. This is a senior associate level role for Regulatory Submission role in Japan. Come Join in Covance and create a great career!

Top 3 Reasons You Should Join US!

  1. Merit-based Career Advancement: 33% of Covance Japan employees received promotion in 2016!! Many of us decided to join Covance Japan because we received career advancement right up front. Promotion depends purely on your ability, not on your age or just because you are with us longer than others.

  2. True Work-Life Balance: We believe your success at work depends on balance in your life. Some of our company benefits flexible work time (core hours 10:00am to 4:00pm) and work-from-home policy (PC and phone will be provided by company). As a result we have 100 % return rate from maternity leave, and some men are taking paternity leave. You do not feel guilty taking PTOs. Managers encourage their members to refresh after your job well done.

  3. Ground-floor Opportunity at a Growing Company: Covance Japan is still a young and growing company with energetic team members. What you say and what you do has huge impact on the entire company now, 3 years, and 5 years into the future. We also make sure we have fun while we work (monthly happy hour, Halloween costume party, Xmas party, family outings to BBQ etc.)!

Develop your career in truly global life sciences company, helping to bring the miracles of medicine to market. Reach out to us for a coffee chat today!

[Responsibilities]

  • Prepare routine CTN and regulatory submissions packages to regulatory authorities in Japan. Will take ownership for specific pieces of work and may be the Regulatory Affairs lead for projects.

  • Assist in the coordination, collection and organization of data and information required by Regulatory Authorities

  • Assist and support Regulatory strategist in preparation PMDA meeting packages and coordination and arrangment of PMDA consultation meetings

  • Assist and provide regulaory support to ICCC services in Japan

  • Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.

  • Assure compliance with regulatory requirements in relation to assigned projects.

  • Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues

  • Work on special regulatory projects as assigned.

Education/Qualifications

  • Bachelor’s Degree in Life Sciences or equivalent.

Experience

  • Excellent communication skills, organization and planning skills and attention to detail.

  • Minimum of 3 years experience in the pharmaceutical industry preferably in regulatory affairs or drug development in Japan

Job Number 2018-17810

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.