Associate Principal Scientist, Regulatory
5 meses atrás
**The Position**
The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule 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.
**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.
**Required Education, Experience and Skills**
- Bachelor’s degree, in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology or Biochemistry - 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) - minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
- Preferred - degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.
- 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.
- 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.
- 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.
OCMC
Secondary Language(s) Job Description
**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for ever
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