Associate Principal Scientist, Regulatory
Há 1 mês
Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes.
The incumbent may manage a team of one to two individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as-needed basis.
**Primary Responsibilities**:
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
- Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Provide regulatory leadership as needed to product in-license/due diligence review, product divestment, and product withdrawal.
- Collaborate with our company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.
**Education Minimum Requirements**:
- Bachelor’s degree (or U.S. equivalent) in Chemistry, Biochemistry, Chemical Engineering, Pharmacy or closely related field plus at least 5 years of relevant regulatory experience including biological/pharmaceutical research, manufacturing, or quality OR
- Master’s degree (or U.S. equivalent) in Chemistry, Biochemistry, Chemical Engineering, Pharmacy or closely related field plus at least 4 years of relevant regulatory experience including biological / pharmaceutical research, manufacturing, or quality.
**Required Experience and Skills**:
- Strong negotiation, interpersonal, written/oral communication and fluent in English language.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project Management.
- Good understanding of change management projects.
Technical Skills:
- Proven experience in critically reviewing detailed 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 superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem-solving.
Leadership Skills:
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal, and negotiating skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
**Preferred Experience and Skills**:
- Direct experience in Regulatory CMC is preferred.
**Secondary Language(s) Job Description**
Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and
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