Job Description
This Role is responsible for developing and implementing Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies, in addition to the preparation and review of information required for development of regulatory Chemistry, Manufacturing and Control dossiers for commercial products.
Regulatory Responsibilities:
Lead global product and project regulatory strategies by identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
Execute regulatory strategies by leading the development, authoring and review of Chemistry, Manufacturing and Control submission components and documentation to support approval supplements/variations, Drug Master Files, New Drug Application/Biologics License Application/Marketing Authorization Application, Annual Reports, Commitment and responses to health authority questions
Liaise with global Chemistry, Manufacturing and Control, Manufacturing Division and external partners including Contract Manufacturing Organizations to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle
Technical Skills:
Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., manufacturing, analytical testing, and quality assurance).
Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems including Veeva.
Leadership Skills:
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills
Qualifications & Skills:
Bachelor's in science, Engineering, or a related field (advanced degree preferred but not required). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
Preferred: At least 5 years pharmaceutical industry experience, or up to 3 years' experience in managing Chemistry, Manufacturing and Control Regulatory submissions for small molecules/vaccines/biologics. Experience in Veeva.
Required Skills:
Adaptability, Biologics License Application (BLA), Cross-Cultural Awareness, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, International Regulatory Compliance, Pharmaceutical Process Development, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions, Regulatory Writing, Strategic Thinking, Technical Writing
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/9/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
