Adalvo
Website:
adalvo.com
Job details:
At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo! 🎯 🚀
We are looking for an enthusiastic VP, Regulatory Affairs to join our dynamic Quality team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.
SUMMARY OF POSITION
The Vice President (VP) of Regulatory Affairs (Generics & Specialty Generics) is responsible for driving the strategic
planning, preparation, and successful execution of regulatory submissions across the United States and Canada. This leadership role focuses heavily on generic drug pathways, including 505 (b)2, Abbreviated New Drug Applications (ANDAs) via the US FDA Office of Generic Drugs (OGD) and New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) via Health Canada's Health Products and Food Branch (HPFB). The VP will oversee a diverse portfolio of complex generic products (e.g., sterile injectables, topicals, and pens), ensuring strict compliance with GDUFA requirements, managing Paragraph IV patent certifications, and leading critical interactions with regulatory health authorities.
KEY RESPONSIBILITIES
- Regulatory Strategy & Pipeline Execution: Develop and implement innovative global regulatory strategies for complex and specialty generic products to ensure rapid, first-cycle approvals in the US and Canada.
- Submission Leadership: Oversee the compilation, review, and high-quality electronic submission (eCTD) of ANDAs to the US FDA and ANDSs to Health Canada, ensuring absolute scientific accuracy and compliance.
- Portfolio Management: Guide regulatory pathways for specialty generics, including Competitive Generic Therapies (CGT), drug-device combinations, and complex dosage forms (injectables, topicals, combination products, pens).
- Patent & Legal Collaboration: Partner closely with Legal Counsel to navigate intellectual property challenges, Paragraph IV patent certifications, First-to-File (FTF) strategies, and regulatory exclusivity periods.
- Health Authority Interfacing: Serve as the primary point of contact for the US FDA (OGD/CDER) and Health Canada (HPFB). Direct the preparation for and execution of formal health authority meetings, scientific advice sessions, and responses to Information Requests (IRs) or Complete Response Letters (CRLs).
- Cross-Functional Guidance: Provide strategic regulatory input to internal and external multi-disciplinary teams across R&D;, Quality Assurance, and Manufacturing regarding Chemistry, Manufacturing, and Controls (CMC), bioequivalence (BE) study designs, and analytical validation protocols.
- Risk Mitigation: Proactively monitor, analyze, and interpret evolving FDA, Health Canada, ICH, and GDUFA guidelines to identify portfolio risks and implement robust compliance mitigation plans.
- Team Leadership: Lead, mentor, and build a high-performing regulatory affairs team, cultivating an environment of technical excellence, accountability, and continuous professional development.
QUALIFICATIONS & REQUIREMENTS
Education: Master's degree in Life Sciences, Pharmacy, Chemistry, or a closely related scientific discipline. Ph.D. is highly recommended.
Experience: Minimum of 15 to 20+ years of progressive regulatory affairs experience within the pharmaceutical industry, with at least 15 years specifically focused on generic or specialty generic drug development and approvals.
Regional Expertise: Deep, proven experience successfully managing US FDA ANDA submissions under GDUFA frameworks and Health Canada HPFB ANDS submissions.
Technical Acumen: Demonstrated technical knowledge of bioequivalence criteria, generic drug CMC specifications, and specific regulatory pathways governing complex dosage forms.
IP Knowledge: Strong foundational understanding of pharmaceutical patent laws, Hatch-Waxman amendments, Paragraph IV filing strategies, and data exclusivity frameworks.
Communication & Influence: Exceptional written and verbal communication skills, with a track record of effective negotiation, presentation, and collaboration with senior leadership and health authorities.
Professional Credentials: Regulatory Affairs Certification (RAC) from RAPS is preferred.
Why join us?
🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.
🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.
🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.
🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.
🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.
Ready to Ignite Your Passion?
If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!
Please be informed that only selected candidates will be contacted.
Click on Apply to know more.
