R&D RA Manager position at a Leading Global Bio-Pharma company
a Blockbuster in Bloodcancer area and currently developing a new area
About Our Client
a Leading Global Bio-Pharma company
1. Work with regulatory team in Summit to implement plans for products for both investigational and marketed products
2. Participate in or lead Japan regulatory sub-team (project team) for assigned product(s) / project(s)
3. Prepare, lead and review major regulatory applications (eg. INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications)
4. Participate in and/or lead regulatory interactions with MHLW/PMDA on assigned projects.
5. Participate or acts as regulatory representative on various cross-functional teams
6. Participate in cross-functional initiatives
7. Maintain and reinforces compliance with Company SOPs and Work practices
8. Provide input and comments on draft regulatory guidance
The Successful Applicant
- Bachelors degree in scientific discipline; Advanced scientific degree preferred.
- More than 10 years pharmaceutical industry experience.
- Good Understanding of the drug development process.
- Specific expert knowledge in one or more key areas expected: Oncology Drug Development / CMC / PK / Clinical / Promotional
- Inter-dependant partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
- Domestic and occasional International travel may be necessary
What's on Offer
15M Base plus Bonus