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 you willing to relocate?
Fraser Dove International is working with a young biotechnology company at clinical stage who are extremely ambitious to move into commercialization in the next two years. They are now at an exciting stage of growth and are looking to increase their headcount to accommodate this. The culture within the organization is lean, fast-paced and collaborative.
As the Senior Director, Regulatory Affairs, you will be responsible for developing and implementing regulatory strategy and lead the health authority submissions and life-cycle management of unique products to serve patients with unmet medical needs.
Discover more about our Senior Director Regulatory Affairs opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Director, Regulatory Affairs, you will be measured against the following objectives:
1) Provide Regulatory strategic leadership
Be the lead for health authority interactions, regulatory submissions and other activities.
2) Subject Matter Expert in Regulatory
Lead meetings and preparations with the FDA and other health authorities to facilitate approval.
3) Be hands-on and work collaboratively across multiple functions
Provide support to the regulatory team and push the sense of urgency for regulatory affairs throughout cross-functional teams.
What you will do:
As the Senior Director, Regulatory Affairs your duties and responsibilities will include:
- Develop and implement the Regulatory Affairs strategy.
- Manage and lead health authority meetings, preparations and submissions.
- Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations.
- Contribute to the strategic leadership and development of policies, procedures and best practices.
- Provide support to the regulatory affairs team in managing, planning, coordinating and preparing all documents submitted to FDA and health authorities in support of INDs, BLAs, MAAs, DMFs and CTAs.
- Serve as a subject matter expert on Regulatory Affairs for the organization.
- Provide de-risking development strategies and evaluating opportunities to accelerate development.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Director, Regulatory Affairs:
- Strong knowledge of FDA regulations.
- Proven experience and success with filing BLAs/MAAs.
- Experienced in setting strategies and preparing regulatory documents.
- FDA and other health authority interaction experience.
- Experience with biologics drug development at early and late stage is desirable.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Performance Bonus
- Stock Options
- Private Pension
Got what it takes?
To apply for the Senior Director, Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant – Hollie Brown – 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 authorized 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 organizations 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 organizations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.