Are you an experienced Regulatory Affairs professional who thrives in a fast-paced environment?
Do you have a passion for implementing Regulatory Affairs strategy?
Are you based on the East Coast, USA or are willing to relocate?
Fraser Dove International is partnered exclusively with an ambitious biotechnology organisation seeking a Regulatory Affairs Professional to developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs.
Discover more about our Associate Director of Regulatory Affairs opportunity; it’s objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Associate Director of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs.
You will provide regulatory input and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration and other Health Authorities worldwide.
What you will do:
As the Associate Director of Regulatory Affairs, your duties and responsibilities will include:
- Provide regulatory strategic input for drug development projects, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines. Provide CMC, preclinical and clinical regulatory input to the overall drug development for assigned projects.
- Provide support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates for assigned projects.
- Interpret and communicate regulatory expectations to stakeholders in order to execute program objectives in compliance with applicable regulations.
- Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment.
- Contributes to the development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company.
What you will bring:
These are the skills and experience you will need to succeed as the Associate Director of Regulatory Affairs:
- Bachelor’s Degree required, (PharmD preferred).
- Minimum of 10 years of experience in regulatory affairs within the bio-pharmaceutical industry. Strong knowledge of FDA regulations and EU CTA requirements.
- Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities.
- Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions required.
- Experience interacting directly with the FDA.
- Experience with biologics drug development is a plus.
- Experience with both early and late stage drug development is a plus.
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
- Ability to thrive in a collaborative and fast-paced team environment.
What you will get:
These are the perks and benefits that will complement your generous base salary:
$160,000 + Benefits
Got what it takes?
To apply for the Associate Director of Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.