Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA

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💎 Seniority level: Director, 7 years

📍 Location: United States

🔍 Industry: Health Tech

🏢 Company: myTomorrows👥 101-250💰 $10,585,001 about 8 years agoPharmaceutical Clinical Trials Medical Health Care

🗣️ Languages: English

⏳ Experience: 7 years

🪄 Skills: LeadershipProject ManagementCross-functional Team LeadershipOperations ManagementCommunication SkillsAnalytical SkillsComplianceTeamworkClient relationship managementQuality AssuranceRisk ManagementTeam managementStrategic thinkingEnglish communicationBudget management

Requirements:

Bachelor’s or Master’s degree in Life Sciences or similar.
At least 7 years of work experience in regulatory and pharmacovigilance roles in biotech/pharma, including specific experience in managing global expanded access programs.
In-depth knowledge of FDA and EU regulations, GMP and ICH guidelines and ability to implement them within the context of expanded access programs.
Experience in effectively managing expanded access teams, including external vendors.
Proven experience in mastering effective communication and negotiation skills internally and with regulatory authorities
Ability to organize, mentor and motivate the team in a quickly growing and agile/flexible environment
Ability to prioritize activities to ensure spending time on the critical priorities, with the highest impact on the organization
Ability to plan your work strategically coupled with a high willingness to also take action yourself
Proven ability to solve complex issues, get to the root cause, foresee potential issues, and proactively mitigate before they happen.

Responsibilities:

Lead the Regulatory Affairs & Pharmacovigilance team.
Develop, structure, and execute regulatory strategies of EAPs.
Act as Subject-Matter Expert for Regulatory Affairs and Pharmacovigilance.
Manage all Regulatory and Pharmacovigilance aspects of EAPs.
Consult clients on strategy for setting up and executing EAPs globally and/or in specific countries.
Structure and maintain an up-to-date working knowledge of Regulatory and Pharmacovigilance regulations and guidelines related to Expanded Access.
Support, control, and manage the Pharmacovigilance services offered to clients
Be responsible for the creation, review and maintenance of SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective Actions and Preventive Actions) assigned to the department
Support the Commercial team on the feasibility and qualification of new Expanded Access Programs
Provide team members with strong leadership, nurture personal development, and ensure a high-performance environment

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