MSD Associate Principle Scientist Regulatory Chemistry 

Kenya, Nairobi County, Nairobi 

327449753

Job Description

Associate Principle Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) (m/f/d)to be based in our new office in Zürich.(

Under direction from Director/Executive Director, the Assoc Principle 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 Assoc Principle Scientist (m/f/d) is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principle Scientist (m/f/d) 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 Sr. Scientist / Scientist in support of their assigned projects.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• 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 / 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

QUALIFICATIONS:

• Bachelor in a science, engineering, or a related field such as Pharmacy, Chemical or Biological Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry

• Advanced degree would be strongly preferred

• A minimum five years ofIndustrial/regulatoryexperience in biologics research, development and/or manufacturing

• Prior Biologics clinical submissions, marketing applications or post approval changes / variations filing experience

• Fluency in English (oral and written), German nice to have

• Willingness to travel up to 10%

• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data

• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner

• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills

• Experience in Device Development or Vaccines is a plus

Current Contingent Workers apply

Not ApplicableNot Indicated

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A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.