Director of Regulatory Affairs – Leading Independent, Medical Research organisation – Hybrid, Wisconsin, USA - $193,138 - $289,706, Paid time off (Vacation, Sick & Personal days)

The Company

Carrot Recruitment have partnered with an independent, Medical research organisation, in their search to appoint a Director of Regulatory Affairs (Pharmaceutical products) to their team. You will be key member of the Regulatory Affairs team, based in the Wisconsin but working across the US. Our client is a specialist Medical research organisation working Mental Health (Depression and anxiety) area of focus.

This is a key hire for the organisation and as such the right candidate must be an experienced Regulatory Affairs senior Director with experience in Authoring, assembling and submission of IND & NDA applications. In the role you, will be responsible for strategic knowledge to small molecule drug development across all stages of a product’s lifecycle (pre-IND through post-licensure) and across functional disciplines (e.g., clinical, nonclinical pharmacology /toxicology, clinical pharmacology, CMC).

The Role

• Skilfully lead communications with FDA and other global regulatory agencies

• Develop, review, submit and follow all regulatory agency submission materials

• Proactively identify and address regulatory compliance issues. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

• Lead, develop, and implement CMC regulatory strategies to ensure on-time and high-quality submissions for Drug Master Files (DMFs), marketing applications (NDA/ANDA), and post-approval lifecycle submissions

• Manage a team of regulatory affairs staff to ensure the team delivers consistent and high-quality work products in a timely manner.

• Communicate regulatory information to team members, partners, and other stakeholders and ensure that the information is interpreted and relayed correctly.

You

• Bachelor’s degree required, preferably in Regulatory Science or a health sciences field.

• A minimum of 10 years of experience in the pharmaceutical industry (small molecule) or a related area. (Proven 2 years in a senior leadership role with strong management skills).

• Strong scientific or clinical research background required.

• Demonstrated knowledge of regulatory affairs, such as 21 CFR 210/211/310/312/314, FDA guidance documents, and ICH guidelines for both development projects and commercial projects, with evidence of successful submissions to FDA, EMA, MHRA, or other health authorities

• Demonstrated track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations.

• Demonstrated CMC regulatory experience with drug substance and/or drug product and API production.

What you should do next

This Director of Regulatory Affairs role is one not to be missed; it encompasses the opportunity to work with a leading independent, Medical research organisation. To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the USA, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.