Regulatory Affairs Vice President
2 weeks ago
Aura BioSearch is a leading bio-pharmaceutical company dedicated to developing innovative therapies for better patient outcomes.
About the RoleWe are seeking an experienced Regulatory Affairs Vice President to lead our global regulatory operations. Reporting to the Senior Vice President of Regulatory, this role involves providing strategic and operational leadership to ensure the efficiency and effectiveness of the Regulatory team and the integrated group.
Key Responsibilities- Develop and execute global regulatory strategies to support development programs and market applications.
- Implement regulatory strategies effectively across various regions.
- Manage the Regulatory team in developing submissions and collaborating with cross-functional teams.
- Oversee planning and execution of submissions, ensuring timely and high-quality documentation.
- Interpret and communicate data effectively within cross-functional teams and with regulatory authorities.
- Maintain alignment with global health authority requirements.
- Prepare risk assessments on regulatory topics, predicting potential issues and developing contingency plans.
- Build and maintain strong relationships with internal and external stakeholders.
- Bachelor's degree in Biochemistry, Biology, Chemistry, or a related field; advanced degree preferred.
- Over 20 years of experience in the bio-pharmaceutical industry, with at least 15 years in Regulatory within pharmaceutical development.
- Proven track record of successful regulatory submissions to the FDA and/or other health authorities, including EMA.
- Strong ability to apply scientific principles to regulatory issues, analyze data, and draw valid conclusions.
- Effective leadership skills, with experience leading both direct reports and integrated teams.
- Excellent interpersonal, verbal, and written communication skills, with the ability to influence and lead others.
The estimated annual salary for this position is $250,000-$300,000, commensurate with experience. Additional benefits include a competitive compensation package, comprehensive health insurance, and opportunities for professional growth and development.
LocationThis role is based in Massachusetts, USA, and requires on-site attendance as part of scale-up.
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