Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)

Job Description

The Position

The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule and/or biological products in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life cycle maintenance phases. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis.  Primary responsibilities include, but are not limited to: 

Responsibilities

• Serve as the CMC Product Lead or support the CMC Product Lead for assigned projects 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 strategy(ies) 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 Organon 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 IND, IMPD, marketing applications, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.   

• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. 

• 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.   Fields of study include Pharmacy, Chemistry, 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) with at least 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field

• At least four (4) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.   

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

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 leader