Local Compliance & Ethics Officer at Teva Germany serving local management and compliance program. Leading compliance initiatives and collaborating with various stakeholders while managing risks and providing guidance.
XI
Hybrid Senior Manager, Regulatory Affairs, Operations
Posted 13 minutes ago
About the role
- Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross-functional teams in a neuroscience-focused biopharmaceutical environment.
Responsibilities
- Regulatory Information Management (RIM) system expertise
- Submission/registration management
- eCTD & publishing integration
- Lifecycle management
- Metadata & data governance
- Workflow and process configuration
- Maintain processes for regulatory submission document formatting
- Manage contractual relationships and workstreams with external publishing vendors
- Serve as the unblinded regulatory person for the sign-off
- Manage the submission of expedited safety reports (i.e., SUSARs)
- Support regulatory program leads and project teams in creating timelines
- Maintain the Xenon regulatory submission calendar and trackers
- Provide advice from an operation’s perspective
- Communicate current and emerging publishing and reporting regulatory requirements
- Advise on and direct the evaluation, selection, and implementation of technology
- Contributes to the development of SOPs, Work Instructions and training materials
- Develop and maintain document templates
- Act in accordance with Company policies
- Some international travel may be required
- Other duties as assigned
Requirements
- Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO)
- A minimum of 5 years’ management level experience in a pharma or biotech environment
- Experience with pharmaceutical regulatory submissions (specifically, eCTD)
- Understanding of the drug development process, FDA/EMA regulations and ICH guidance
- Expert proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat
- Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions
- Familiarity with eCTD publishing software
- Understanding of best practices for regulatory filing planning
- Demonstrate strong initiative and drive
- Ability to work successfully in cross-functional teams
- Strong interpersonal and communication skills
Benefits
- medical
- dental
- vision
- short-& long-term disability
- accidental death & dismemberment
- life insurance programs
- Employee Assistance Program
- travel insurance
- retirement savings programs with company matching contributions
- vacation
- personal days
- sick days
- end-of-year company shutdown
- expanding Training, Learning & Development program
- Tuition Assistance program for advanced degrees
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