NEW ROLE ** Asia Pacific Regulatory Liaisons ** Expanding ONCOLOGY Pipeline ** China or Japan ** Gain more RA Strategy and Liaison for China and Japan!

Reference: 47748

Expiry Date: 01-04-2024

Category Biotech

Salary: Competitive

Job Type: Full Time

Location:
Département de Paris
Франция

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Job Description

My client, a SME (Small to Medium Sized) Bio-Pharmaceutical organization, is enjoying a  BIG growth period and expansion due to a significant number of Regulatory approvals in their nascent Oncology pipeline specifically in rarer Oncology Indications (Solid Tumor and Haemo). As part of this, my client is #hiring for 2 new Asia Pac Key Country Partners to focus on Japan, China and HK.

What I like about these roles are:-

  • Growing Oncology Portfolio & Pipeline: our client is hitting double digit growth consistently and has over achieved its product targets early in advance by 2 years with a recent string of Regulatory approvals to their credit and many Line Extension New Indications pending (with a near 100% success rate so far)
  • Variety: you will support LEs and INDs for Bridging and Registration studies as well as Phase 1/2 INDs for NMEs – you will collaborate with the countries local teams to validate and shape clinical phase submissions not just MAAs and LEs
  • Support & Visibility: coached and led in matrix to the GRL and Global Regulatory subteam, acting as the bridge between global, the regulatory and global project team and the local affiliates’ teams
  • Focus: it is only working on international Majors not ASEAN or smaller countries so you can build up a strong working relationship with your chosen country (China or Japan), working across multiple LE New Indication filings and supporting CTAs for early stage assets (variety)

About You …

  • Prior experience in International which could be LATAM, ASEAN, ME or CE and E in Rx drug registrations; prior experience in co-developing local clinical phase OR filing strategies; prior experience means as a guide 6.5-10 plus years (we have bandwidth on package)
  • The line manager values the experience in working with challenging international Regulators as more important per se than working just one of these countries - if you have worked with Australia TGA, China FDA, SK FDA, PMDA or Health Canada or ANVISA or similar, this is sufficient! 
  • Mentoring & Coaching: you will start your journey in growing with the company with the support of the team and a ‘buddy’, and the role comes with fully expenses international relocation to a central European city in a French speaking part of the world (core dossier and project team meetings are in English)
  • An interest in Oncology: you might have now or want to gain Oncology experience and be scientifically curious, and know you to use both liaison and regulatory intelligence skills to help shape more effective strategies in the region
  • You will want to develop either into strategy or eventually people management (you will coach Trainees and Industrial Rotations from the start)

About Me – How to apply!

I am retained by and working directly with the client and will help you every step of the way. To apply please contact me, Christian, at +44.207.801.3382, or send a full CV to Christian@AdvTalent.com – I look forward to hearing from you!