Regulatory Affairs Fellow - Rotational Pharma Strategy

MBX Biosciences, Inc.; Burlington (MA); Ibrido; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

MBX Biosciences, Inc. invites PharmD Fellows to join a 2-year Regulatory Affairs program in collaboration with Purdue University. The fellow rotates across Regulatory Science, CMC, Operations, and QA, with a mix of MBX and Purdue activities and optional department rotations.

Hybrid work and networking opportunities strengthen professional development. Participants gain exposure to IND/CTA submissions, regulatory strategy, and cross-functional project management, preparing for leadership roles in

Competenze

• Excellent problem-solving and strategic thinking for regulatory challenges.
• Strong interpersonal and written/oral communication in cross-functional teams.
• PharmD degree with ability to navigate regulatory processes and approvals.

Mansioni

• Assist in coordinating US and global regulatory documentation submissions.
• Provide operational oversight for ongoing clinical trials and regulatory activities.
• Support cross-functional teams to develop regulatory strategies for programs.
• Maintain regulatory trackers and ensure timely deliverables across groups.

Conoscenze

Problem solving

Strategic thinking

Interpersonal skills

Communication skills

Formazione

PharmD degree

Strumenti

Microsoft Office

Descrizione del lavoro

MBX Biosciences, Inc. invites PharmD Fellows to join a 2-year Regulatory Affairs program in collaboration with Purdue University. The fellow rotates across Regulatory Science, CMC, Operations, and QA, with a mix of MBX and Purdue activities and optional department rotations.

Hybrid work and networking opportunities strengthen professional development. Participants gain exposure to IND/CTA submissions, regulatory strategy, and cross-functional project management, preparing for leadership roles in