Senior Director Regulatory Affairs

Cambridge, Massachusetts

Summary:

Seeking an experienced Senior Director of Regulatory Affairs with strong strategic leadership skills to hit the ground running to lead and support an established and growing regulatory group in the Greater Boston area. This Senior Director will provide oversight and direction to the global strategy teams to ensure that the regulatory submissions and compliance support the goals and objectives of the company. This person will serve as the departments subject matter expert for all global clinical studies and global submissions (IND & NDA). Seeking strong global expertise, along with proven leadership skills with a successful track record of developing and executing regulatory strategy, while working collaboratively cross-functionally with the team. You will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Prior hands-on experience managing and leading studies and submissions and have had direct interactions with global health authorities is required. Looking for someone that's confident and experienced within regulatory to lead development, as well as, plan, execute, interpret and present all regulatory strategy, while working collaboratively and cross-functionally with the team.

• Oversee and manage preparation and submissions (pre-IND, IND/CTA, BLA/MAA, etc.) of high-quality regulatory dossiers in the US and EU according to set timelines; this will require, strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science.
• Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
• Ensure global regulatory requirements and strategy are understood by project teams.
• Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications
• Lead interactions with FDA and other global Health Authorities

Professional Qualifications:

• Master's or Advanced degrees (PhD/PharmD) are preferred; BS degree in life sciences or equivalent is required.
• 15 years of experience in a biotech/pharmaceutical setting within regulatory affairs
• Strong knowledge and understanding of US and international regulations (i.e.: cGMP, GCP, GLP, ICH guidance documents) & an expertise withglobal regulatory submissions and compliance with all Health Authorities, i.e.: US FDA, EMA, ROW)
• Strong ability to work and manage multiple projects at any given time
• Successful track record of direct interactions/leading major global health authorities.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high-profile development program.
• Strong ability to work and manage multiple projects at any given time.
• Key skills: Excellent communication skills, both written and verbal communication, excellent organizational skills. Professional, proactive demeanor and team player attitude.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.