Job Description
Are you a visionary Regulatory Affairs professional ready to make a profound impact on global patient health? InnovaBio Pharma, a rapidly growing leader in novel therapeutics, is seeking an exceptional Senior Regulatory Affairs Lead to spearhead our global submission strategies. Based in the heart of Princeton, NJ's thriving biotech hub, you will play a critical role in bringing life-changing medications from development to market.
At InnovaBio, we believe in fostering an environment where innovation thrives, and every team member contributes to our mission. This isn't just a job; it's an opportunity to lead, strategize, and shape the future of medicine. If you're passionate about navigating complex regulatory landscapes and accelerating drug development, we invite you to join our dynamic team and make your mark.
We offer a highly competitive salary, comprehensive benefits, and a culture that supports professional growth and work-life balance. Your expertise will be vital in ensuring our groundbreaking therapies achieve timely approval across international markets.
Responsibilities
- Develop, lead, and execute global regulatory strategies for assigned pharmaceutical products throughout their lifecycle.
- Manage the preparation, review, and submission of complex regulatory documents, including INDs, NDAs/BLAs, MAAs, and their amendments, to health authorities worldwide (e.g., FDA, EMA, Health Canada).
- Serve as the primary regulatory contact for health authority interactions, leading critical meetings and negotiations.
- Ensure all submissions and regulatory activities comply with applicable international regulations, guidelines (e.g., ICH), and company SOPs.
- Provide strategic regulatory guidance to cross-functional development teams (Clinical, Nonclinical, CMC, Quality, etc.).
- Assess the impact of new and evolving regulations on ongoing development programs and recommend appropriate actions.
- Mentor junior regulatory staff and contribute to the development of best practices within the regulatory affairs department.
Qualifications
- Doctorate (Ph.D., Pharm.D., M.D.) in a scientific discipline preferred; Master's or Bachelor's degree with extensive relevant experience will be considered.
- Minimum of 8+ years of progressive experience in Pharmaceutical Regulatory Affairs, with a strong focus on global submissions.
- Demonstrated expertise in navigating regulatory requirements for novel drug products across various therapeutic areas.
- In-depth knowledge of FDA (e.g., 21 CFR), EMA, ICH guidelines, and other major international regulatory frameworks.
- Proven track record of successful IND, NDA/BLA, or MAA submissions and approvals.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly and concisely.
- Strong leadership and project management abilities, with experience leading cross-functional teams.
- Proficiency with eCTD publishing software and electronic submission processes.