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

🔥 18 hours 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

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Organon

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2021

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Organon is an independent global healthcare company with a focus on improving the health of women throughout their lives. The company has a diverse portfolio that covers women's health, biosimilars, and established brands, offering therapies for a wide array of conditions including reproductive health, cardiovascular disease, neurology, autoimmune, and respiratory conditions. Organon is active in over 150 markets worldwide and is committed to delivering medicines and devices that advance women's health at all life stages. Additionally, the company works on biosimilars to provide more accessible treatment options. Organon aims to create a brighter future and better health outcomes for women through its comprehensive healthcare solutions.

📋 Description

• Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products • Lead preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes • Serve as CMC Product Lead for assigned products and deliver all regulatory milestones across the product lifecycle • Lead global product and project regulatory strategies • Assess CMC changes, identify global regulatory requirements, evaluate supporting documentation, and identify potential risks • Lead development, authoring, and review of CMC submission components and documentation • Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions • Provide regulatory leadership for product in-license/due diligence reviews, product divestment, and product withdrawal • Collaborate with Organon Manufacturing & Supply colleagues and external partners on compliant change management • Manage CMC documentation according to established business processes and systems • Assess and communicate regulatory risks and propose mitigation strategies • Identify, communicate, and escalate regulatory issues to Organon Regulatory CMC management • May manage 1 to 2 individual contributors and/or outsourcing partners • Support project team goals and organizational initiatives as needed

🎯 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, including biological/pharmaceutical research, manufacturing, testing, or a related field • 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 • Ability to communicate complex issues succinctly and logically • Strong listening skills • Sound understanding of related fields such as manufacturing, analytical, and quality assurance • Ability to develop creative and imaginative approaches to new and diverse problem solving • Ability to generate innovative solutions to complex regulatory problems • Ability to work with and communicate effectively with key stakeholders • 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 associated 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

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