Associate Principal Scientist (Associate Director) Regulatory Affairs

Job Description

GRACS CMC – Associate Principal Scientist, CMC, R4 – Pharm Pre-approval

Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for all assigned development products.  Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:

• Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures. 

• Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.

• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.

• Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.

• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems. 

• Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed

• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company's pharmaceutical products worldwide. 

• Conduct all activities with an unwavering focus on compliance

Education Requirements:

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry

Required Experience and Skills:

• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields. 

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

Preferred Experience and Skills:

• The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, formulation and process development, analytical, quality assurance, novel modality and technologies such as synthetic peptides and biocatalysis).  

• The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. 

• He/she must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role. 

• The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams.

• He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. 

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

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US and Puerto Rico Residents Only:

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