Associate Principal Scientist, Regulatory Chemistry Manufacturing – Controls CMC Product Lead

🔥 4 minutes ago

🌐 United States, United Kingdom, +1 more countries – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote 🇧🇪 Belgium – Remote

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧬 Research Scientist

👻 Ghost score 10%

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Organon

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

💰 $1G Post-IPO Debt - Organon on 2024-05

Healthcare • Pharmaceuticals

Organon is a global healthcare company focused on improving the health of women throughout their lives. Its diversified portfolio includes more than 70 medicines and devices across women’s health (including fertility, contraception, maternal health, and vaginal health) and general medicines such as biosimilars for conditions like cardiovascular disease, neurology, dermatology, autoimmune and respiratory illnesses. Organon brings therapies to more than 140 markets worldwide and emphasizes access, affordability, and programs supporting patients and healthcare professionals.

📋 Description

• Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products • Serve as CMC Product Lead and deliver regulatory milestones throughout the product lifecycle • Lead global product and project regulatory strategies • Develop, author, and review CMC submission components and documentation • Prepare and submit CMC dossiers for lifecycle maintenance submissions, original registrations, and post-approval changes • Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions • Provide regulatory leadership for product in-license/due diligence reviews, divestments, and withdrawals • Collaborate with Manufacturing & Supply colleagues and external partners on compliant change management • Assess and communicate regulatory risks and propose mitigation strategies • Identify, communicate, and escalate regulatory issues to Regulatory CMC management • Manage a team of 1 to 2 individual contributors and/or outsourcing partners as needed • Support project team goals and organizational initiatives

🎯 Requirements

• Bachelor’s degree in a science, engineering, or related field with at least 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field; OR advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience • Proficient in English; additional language skills are a plus • Proven experience critically reviewing detailed scientific information and assessing technical merits and scientific rationale • Superior oral and written communication skills in multicultural settings • Understanding of related fields such as manufacturing, analytical, and quality assurance • Ability to generate innovative solutions to complex regulatory problems • Flexibility in responding to changing priorities or unexpected events • Effective leadership, communication, interpersonal, and negotiating skills • Ability to lead direct or matrixed colleagues to deliver business commitments and project timelines • Experience in Regulatory CMC post-approval lifecycle management preferred • Must be able to satisfy applicable travel and credentialing requirements, including vaccination prerequisites • No visa sponsorship

🏖️ Benefits

• Retirement savings plan • Paid vacation and holiday time • Paid caregiver/parental and medical leave • Health benefits including medical, prescription drug, dental, and vision coverage • Flex Time • Remote Work