Welcome to our East Coast Global Development Hub, a melting pot of life science innovation nestled in the vibrant communities of Lexington, MA, and Plainsboro, NJ. Here, we're pioneering the future of research and development by bridging the gap between biotech agility and pharmaceutical stability. With cutting-edge facilities and a focus on collaboration and partnerships, we're on a mission to revolutionize healthcare across various innovative modalities and therapeutic areas. If you're passionate about making a tangible impact on human health and ready to join a community where every day is about changing lives, we'd love to meet you.
The Opportunity
We're on the lookout for a science-enthusiast with a knack for global regulatory intricacies and a heart for teamwork. As our Associate Director - Global Regulatory Lead, you'll spearhead a talented team dedicated to navigating the regulatory pathways for groundbreaking medical solutions. Your leadership will be pivotal in strategizing and delivering successful regulatory outcomes, ensuring we stay on the forefront of medical innovation.
Key Relationships
Reporting to the Executive Director of Regulatory Affairs and maintaining a crucial connection with our Regulatory Affairs CMC & Device Area, your role is at the intersection of leadership and collaboration, empowering you to make a significant impact.
Your Role
Innovate within our Global Project Team, applying your expertise to shape development strategies and regulatory achievements.
Direct a skilled Global Regulatory Matrixed Team, crafting and implementing strategies that meet our ambitious goals.
Engage with health authorities, leading preparations and discussions to advocate for our groundbreaking projects.
Manage global filing efforts, ensuring quality and timely submissions.
Contribute to internal strategy discussions, highlighting regulatory considerations and solutions.
Stay ahead of industry and regulatory trends to keep our strategies cutting-edge.
Adapt to a dynamic work environment, managing responsibilities across cultures and time zones with grace and effectiveness.
Work Environment
Flexible work options with a preference for a hybrid setup in Lexington, MA, or Plainsboro, NJ. Remote work is also on the table.
Travel is minimal, but a readiness to engage in occasional overnight stays is appreciated.
The physical demands of this role are light, with minimal requirements for lifting.
What You Bring
A Bachelor's degree is essential, with a preference for advanced qualifications.
At least 8 years of experience in pharmaceutical or related fields, with a solid background in drug
development.
Expert understanding of global regulatory requirements for drugs and biologics.
A proven track record of developing and executing strategic regulatory plans.
Direct experience with international regulatory bodies, including leading discussions with the FDA.
A strong background in rare disease research, innovative trial designs, or expedited pathways is highly valued.
Leadership skills that inspire teamwork and drive towards common goals.
Exceptional communication abilities and problem-solving skills.
A positive outlook and resilience in fast-paced environments.
Our Commitment
We're dedicated to fostering an inclusive workplace that celebrates diversity in all forms. We believe in equal opportunities for all our team members and are committed to being a company that cares not just about being the best in the world, but the best for the world. Join us in our journey towards creating life-changing impacts for the patients we serve, our employees, and the communities around us.
Employment Type: Full-Time
Salary: $ 65,000.00 Per Year
