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Merck · 11 hours ago

Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC

USA - Maryland - Rockville

Full-time

Hybrid

Senior Level, Lead/Staff

$142K/yr - $224K/yr

5+ years exp

Merck is a global healthcare company that is seeking an Associate Principal Scientist in Regulatory Affairs for their CMC team. The role involves developing and implementing regulatory strategies for pharmaceutical pipeline products, focusing on small molecule respiratory/inhalation product development and ensuring compliance with global regulations.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of regulatory success together with risk mitigation measures

Lead development and execution of global product and project regulatory strategy(ices) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks

Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects

Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team

Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems

Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to GRACS CMC management, as needed

Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CRO/CMOs) to execute program objectives in compliance with applicable regulations

Partner with our quality colleagues to prepare for and support pre-approval and regulatory inspections, ensuring launch readiness and regulatory success

Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our Company's pharmaceutical products worldwide

Conduct all activities with an unwavering focus on compliance

Qualification

Regulatory CMCRegulatory Strategy DevelopmentRegulatory SubmissionsPharmaceutical Process DevelopmentBiochemistryChemical EngineeringMicrobiologyTechnical LeadershipBiological SciencesImmunochemistryDry Powder Inhalers (DPI)Electronic Common Technical Document (eCTD)International Regulatory ComplianceMolecular MicrobiologyDocumentations

Required

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

At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields

The candidate must be proficient in English; additional language skills are a plus

Biochemistry

Biological Sciences

Biologics License Application (BLA)

Chemical Engineering

Documentations

Dry Powder Inhalers (DPI)

Electronic Common Technical Document (eCTD)

Immunochemistry

International Regulatory Compliance

Microbiology

Molecular Microbiology

Pharmaceutical Process Development

Pharmaceutical Research

Regulatory CMC

Regulatory Compliance

Regulatory Strategy Development

Regulatory Submissions

Regulatory Writing

Technical Leadership

Preferred

The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)

Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required

Preferably, the candidates should be familiar with the latest global regulatory guidance's and pharmacopeial methods with a demonstrated ability to apply them to build regulatory strategies related to Inhalation products

The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events

They must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role

The candidate must have excellent interpersonal, verbal, and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams

They must have proven experience in critically reviewing detailed scientific information and assessing the technical arguments presented with clear and concise conclusions adequately supported by data