Expiry Date: 08-11-2021
Category Regulatory Affairs
Job Type: Full Time
Global Regulatory Lead ** Remote OR Relocate (Various locations) ** Early or Late Dev RA Strategy
Please note: this role is based remote or from a number of locations in Europe, please call for details. If you have received as a hotlink, we have validated your location before sending.
About My Client
My client has a long history of developing drugs in neurology for many decades, and HQ’d in the Scandic region, and offers a culture of autonomy and transparency, is sized well to be able to allow you to work with senior stakeholders and be part of the core project team without politics or overbearing hierarchy. This role is to sit in the global project team(s) for your assigned programs, and lead the definition and shaping of global regulatory strategy for NMEs in early and late development as well as lead new indications for inline products. The PLs generally have a development or discovery background. Regulatory starts in pre-clinical not in Ph 1.
This organization support a niche speciality pipeline which includes neuro and some rare diseases and have existing in line products marketed globally. The company are stable, listed on a stock exchange, but managed through a private foundation, so company thinks and acts more long-term than most. The global head is very well known, for her collegiate approach, supportive communication style, and for being energetic and involved.
About The Role
You will see yourself as a highly capable Associate Director or Director level individual, you might possibly work for a top 10 pharmaceutical company and now want to work for an organization led from Europe with a more compatible approach to work-life balance and quality of working life. You will have either direct experience or indirect to the US regulatory framework, and a good understanding of how the components of drug development come together to enable effective medicines. The GRLs in this company support clinical and market access decision making, have a seat at the right table, and are considered strategic partners.
You will develop regulatory strategy by working with your project team and partners, be accountable for health authority meetings worldwide, by using LOCs or managing it directly, be part of Go No Go decision making and governance, oversee the preparation of US INDs, NDAs, sNDAs as well as EU and International CTAs, MAAs and line extensions / expansions. You will lead the regulatory sub-team during filings.
To apply for this role, please contact me Matt Greig in the first instance, or Theo Moore on +44 7918679405 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs. Alternatively, please apply by pressing the red “Apply for position” button.
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