Associate Principal Scientist, Regulatory Affairs (m/f/d)

at  MSD

Job Description
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are currently looking for an experienced Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) to be based in our new office in Zürich.
Under direction from Director/Executive Director, the Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization’s biologics product franchises in accordance with domestic and international regulations and guidance. The Associate Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will assist in or be part of team that is responsible for development and the implementation of internal regulatory strategies and provides mentoring and coaching to Senior Scientist or Scientist in support of their assigned projects.

WHO WE ARE …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

TRAVEL REQUIREMENTS:

No Travel Required

• Participation in the authorization process to prioritize submissions.
• In depth knowledge of global CMC guidelines including but not limited to clinical submissions (IND/IMPD), marketing application (original and supplemental), and/or post approval changes and variations.
• Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
• Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post approval change documentation according to defined timelines.
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
• Lead authoring of clear, concise and effective submissions according to defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.