Associate Principal Scientist, Regulatory Affairs

MSD Malaysia; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement

Paid holidays

Vacation time

Compassionate and sick days

Job summary

MSD Malaysia seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for biologics with a strong track record in IND/BLA submissions.

The role includes authoring submissions, cross-functional collaboration, mentoring team members, and driving regulatory Excellence across programs. Competitive compensation and comprehensive benefits are offered.

Qualifications

• 10+ years of biologics CMC regulatory experience including IND/BLA and post-approval changes.
• Experience with regulatory interactions and agency responses across global submissions.
• Strong ability to lead cross-functional teams and mentor scientists.

Responsibilities

• Prioritize submissions in the authorization process.
• Develop and execute global regulatory strategies for INDs/BLAs.
• Lead authoring of regulatory submissions and responses to agencies.
• Collaborate with partner groups to ensure accuracy and completeness of submissions.
• Mentor Senior Scientists and Scientists on assigned projects.

Skills

Regulatory Affairs

CMC

Biologics

IND/BLA Experience

eCTD

Regulatory Submissions

Regulatory Writing

Leadership

Project Management

Cross-Cultural Communication

Education

B.S. in science/engineering

Advanced degree preferred

Tools

eCTD Tools

Job description

Associate Principal Scientist, Regulatory CMC - Biologics (R4)

This Associate Principal Scientist position is equivalent to an Associate Director position. 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 the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Senior Scientist / Scientist in support of their assigned projects.

Responsibilities

• Participation in the authorization process to prioritize submissions.
• In-depth knowledge of global Chemistry, Manufacturing, and Controls regulatory guidelines regarding Investigational New Drug Applications, Biologics License Applications, and post-approval changes.
• 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 Investigational New Drug Applications, Biologics License Applications, and 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 Clinical Trial Applications, Investigational New Drug Applications, Biologics License Applications, and global post-approval 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.

Education Minimum Requirement

• B.S. in a science, engineering, or a related field (advanced degree preferred).
• Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Required Experience and Skills

• Prior Biologics Investigational New Drug Application (IND), License Application (BLA) and/or post approval filing experience with at least 10 years subject matter expertise in biologics Chemistry, Manufacturing, and Controls development or manufacturing.
• Experience in biologics regulatory Chemistry, Manufacturing and Control in both pre-approval and registration required, with experience authoring agency interactions, responses to questions, and Investigational New Drug Application, Investigational Medicinal Product Dossier, and Biologics License Application sections.
• 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 complex 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 flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

Preferred Experience and Skills

• Experience with antibody-drug conjugates (ADCs), combination products and/or complex dosage forms through to commercialization.
• Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry.

Required Skills

• Adaptability
• Biochemistry
• Biologics License Application (BLA)
• Biology
• Cognitive Flexibility
• Commercialization
• Cross-Cultural Awareness
• Detail-Oriented
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• International Regulatory Compliance
• Lateral Thinking
• Next Generation Science Standards
• Pharmaceutical Process Development
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Compliance
• Regulatory Documents
• Regulatory Management
• Regulatory Processes
• Regulatory Strategy Development
• Regulatory Submissions
• Regulatory Writing
• Scientific Analysis {+ 6 more}

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

The application deadline for this position is stated on this posting.