Expiry Date: 31-10-2023
Category Regulatory Affairs
Job Type: Full Time
If you are looking for an exciting new role with a reputable, financially stable and growing Bio/Pharma company with 6 Billion T/O with a strong and diverse pipeline, offering generous packages, where you will operate as the Director, Global Regulatory CMC Lead for mid to and late-stage development, and new major global MAA rollouts, then this could be the role for you! The role will report to the Global Head of CMC RA who is based in Europe. The company allows fully remote working with travel irregularly and not often! The company has a European culture and most of the Technical team are EU based.
Our client has a very successful recent history in bringing innovative therapies for cardio-metabolism and neurological diseases and are adding even more therapy areas to their pipeline. As the global team grows, they are also moving into new modalities and moving into new regions, supporting a fast moving pipeline and new lifecycle (some of their products are in Oncology).
About the role and your experience:
- As the global regulatory CMC lead, you will cover early, late, and major international expansion projects
- You will represent Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters, making sure that the company submissions (CTAs/IMPDs/INDs/MAs/NDAs) are complete and compliant
This is not just a lifecycle maintenance role, but a position that will allow the right person to manage processes, author strategy and improve systems, as new technologies are being added to the marketed products and new molecules go into emerging markets.
That is why:
- You must have proven leadership experience and the ability to work cross-functionally and across cultures with strong communication, excellent regulatory CMC knowledge, and competence in leading cross-functional teams, operating within a matrix organizational structure
- You would need to have both EU and US experience, as well as experience in working on Small Molecules incl. Solid Dose, but you would also be working on their new Oligonucleotide assets in early development (for Neuro and Oncology)
- You would be eager to lead the strategic input for newly approved products in major countries like Brazil, Canada, China, and Japan
The package for this role is exceptional and includes a strong basic salary, bonus, stock with a good vesting period, extended parental leave, and over a month of PTO. The position can also be fully remote.
To apply for this role, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or press the red “Apply for position” button or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.