Head of Regulatory Affairs, Advertising

Head of Regulatory Affairs, Advertising & Promotion

Rare Disease Biotech

Location- Remote in the United States, with a strong preference to a candidate living in East Coast time zone. Occasional international travel may be required.

About the Company

We are working with a European biotech organisation, who are dedicated to improving the lives of patients with rare diseases. They have achieved multiple global filing success from the FDA, EMA and PMDA, and are now launching into further markets around the world. The portfolio ranges from phase 2 development to approved products, with multiple new indications currently being explored across different therapeutic areas including immunology, nephrology & haematology.

About the Role

This role is an exciting opportunity to join as the Head of the Advertising & Promotion team. Reporting into the Head of Global Regulatory Policy, Intelligence & Ad Promo, this role is a core member of the Regulatory leadership team & will manage a team of direct reports.

You will lead & direct post-marketing regulatory activities for the company portfolio, including regulatory review & approval of US promotional, corporate & medical communications, submissions to FDA OPDP/ APLB, and you will be the owner of the global material review process. You will lead interactions with the FDA OPDP, including taking a lead of review & escalation meetings. You will be a very important member of a team who are dedicated to developing & delivering innovative therapies to improve the lives of patients who live with a rare disease.

About the Candidate

We are looking for candidates who have the below experience:

At least 5 years as a Regulatory Advertising & Promotion professional, ideally you will have worked in the pharmaceutical industry for at least 15 years tooCore experience in Ad Promo regulations, FDA guidance documents and promotional & medical review supporting product communicationsKey understanding of FDA promotional regulations, trends & regulatory landscapePrior experience in rare disease, immunology, haematology or oncology would be very beneficialPeople leadership experience, managing a team of direct reportsA willingness to work operationally and \"hands-on\" when required to get tasks completedA desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.Please apply with an up to date CV for consideration.