Job Description

We have a new RA Associate Director position with a Greater Boston-based Rare Disease Biotech, which is well-funded with a broad portfolio of TA's and indications across a variety of modalities who are led by a talented and highly regarded and very friendly and approachable leadership team.

Our client is expanding and is looking for a highly motivated, detail-oriented and confident Regulatory Affairs professional who enjoys US and/or Global strategy and high levels of project responsibility. The role comes with mentoring from the Global Head of Regulatory Affairs around strategy and stakeholder engagement and you will be working in RNA meds, with some 1^st in class indications.

You will act as a primary interface with the FDA for several development compounds and manage the preparation, submission and approval of regulatory applications such as pre-IND/IND/CTA’s from phase I to phase III and designation requests (orphan, PiPs, fast-track, PRIME etc).  You will also review and provide strategic regulatory input on briefing documents for FDA meetings (Type B and Type C – Written Responses) and EMA scientific advice, in a role where you will gain hands-on EU experience.

This will be a senior role where your strategy and plans will be discussed at the highest level within the organization and you will be given room to grow and take on new levels of responsibility. In return, our client will give you the platform to take indications from phase 1 through to NDA/BLA/MAA.

In this role you will be:

• Working in a collaborative team of 6 experienced Regulatory professionals for both the US and EU submission activities
• Preparing with the GRL, regulatory strategy and briefing documents for US / EU regional agencies as well as preparing to coordinating INDs, CTAs, ODD's, PIPs, and assessing opportunities for US Breakthrough Therapy Designation or Priority Medicines
• Leading the timely preparation, review, and submission of documents to regulatory authorities, and ensuring adherence with the internal SOPs and applicable regulatory requirements and best industry practices; providing regulatory intelligence and regulatory impact assessments.
• Supporting the GRLs with planning and execution of regulatory strategies and plans, using CROs and Vendors.

Requirements:

• BS, MS, or PhD degree with 6+ years in Regulatory affairs development in early or late phase
• Experienced in the preparation of regulatory IND/CTA dossiers, ODD's, PIPs, Scientific advice 
• Ability to communicate regulatory strategy, submission documents and plans both internally and externally.

To apply:

If you find this opportunity exciting and you would like to apply, please, send a full CV to: Christian@AdvTalent.com or call us on 908-332-9157 and we will reply by return – We look forward to your application!