myTomorrows
Regulatory Affairs Manager (Expanded Access Programs)
US, Remote
Sponsorship not specifiedDetected 1 day ago
ExcelSupply ChainFDA RegulatoryPharmacovigilanceCommunicationCollaborationSharePointRegulatory Affairs
About the role
- Regulatory Affairs & Pharmacovigilance Manager
- As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally.
- In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation.
Responsibilities
- Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
- Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how).
- Collaborate with the Commercial team to support new EAPs.
- Policies to support working parents.
Requirements
- Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access.
- Working knowledge of fundamental principles of Pharmacovigilance is required.
- A Bachelor's or Master's degree in Life Sciences or a related field
- Experience working directly with clients or external stakeholders in a professional setting
- Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions
- Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint)
- Solid understanding of national and international legislation and regulation relating to Expanded Access
- Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus
- Comfortable collaborating across teams and working in a cross-functional environment
Nice to have
- Strong communication skills (written and verbal) in English
- able to convey complex topics clearly to both internal teams and external parties.
- Knowledge of additional languages is a plus
Compensation
- Enjoy monthly events hosted by our vibrant Culture Club as well as an annual 'myTomorrowland' company-wide celebration!
Benefits
- Competitive salary, annual performance bonus and an Employee Stock Option Plan.
- Great career development opportunities in a fast-growing company.
- Learning and development budget alongside internal knowledge sharing sessions.
- Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits.
Equal opportunity
- Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated.
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