VP Regulatory Affairs

🕒 March 13

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 Description

• At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. • - **Lead regulatory activities and team management**: Assist clients with regulatory aspects of drug, biologic, or medical device products; provide counsel, manage the regulatory team (potentially with direct reports), and translate requirements into practical plans while ensuring timely, scientifically valid submissions. • - **Oversee HA interactions and project leadership**: Lead/participate in Health Authority communications (e.g., meetings, teleconferences); review/author regulatory content for submissions; contribute expertise on drug/device development as a Leadership team member reporting to Senior Leadership, serving on project teams in roles like Subject Matter Expert or Project Lead.

🎯 Requirements

• - B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development • - Advanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU/UK, and Canada • - RAC credentials preferred • Skills: • - Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English • - Strong computer skills, including SharePoint, Word, Excel, and PowerPoint • - Quality focus • - Strong emotional intelligence, customer focused leadership and decision-making skills · Innovative, creative, and practical thinking including problem-solving skills.

🏖️ Benefits

• **Benefits of working at Allucent include:** • - Comprehensive benefits package per location • - Competitive salaries per location • - Departmental Study/Training Budget for furthering professional development • - Flexible Working hours (within reason) • - Opportunity for remote/hybrid* working depending on location • - Leadership and mentoring opportunities • - Participation in our Buddy Program as a new or existing employee • - Internal growth opportunities and career progression • - Financially rewarding internal employee referral program