Remote Biosimilars Regulatory Affairs Consultant

Pharmavise Corporation; Poland; Remote; PLN 318.000 - 478.000; Teilzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

Pharmavise Consulting Corp. is seeking a Regulatory Affairs Biosimilars Per Diem Consultant to provide expert regulatory guidance for biosimilars development from development through commercialization.

The role involves reviewing regional guidelines, preparing and maintaining regulatory submissions (INDs, BLAs, variations), and coordinating with cross-functional teams to align strategy. The position is remote, offering opportunities to engage with international regulators and contribute to

Qualifikationen

• Bachelor's degree in a scientific field is required.
• Minimum 8 years of regulatory affairs experience in pharma/biotech, biosimilars preferred.
• Experience with regulatory submissions for biosimilars (INDs/BLAs/variations).
• Strong communication and stakeholder management abilities.

Aufgaben

• Provide expert regulatory affairs guidance for biosimilars development projects.
• Review regulatory requirements and guidelines for biosimilars across regions.
• Assist in preparation, submission, and maintenance of regulatory submissions (INDs, BLAs, variations).
• Collaborate with cross-functional teams to align regulatory strategy and objectives.
• Stay updated on biosimilars regulatory developments worldwide.
• Participate in meetings with regulatory authorities as needed.
• Support regulatory inspections and audits.

Kenntnisse

Regulatory affairs

Biosimilars

INDs/BLAs

Regulatory submissions

Communication skills

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

Pharmavise Consulting Corp. is seeking a Regulatory Affairs Biosimilars Per Diem Consultant to provide expert regulatory guidance for biosimilars development from development through commercialization.

The role involves reviewing regional guidelines, preparing and maintaining regulatory submissions (INDs, BLAs, variations), and coordinating with cross-functional teams to align strategy. The position is remote, offering opportunities to engage with international regulators and contribute to