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Senior Regulatory Associate CMC

Company Name:
Carlyle Conlan
Carlyle & Conlan has been engaged to identify and evaluate candidates, for a client located in the RTP, NC area for the role of Senior Regulatory Affairs Associate CMC.
Our Client:
Our client is a specialty pharmaceutical company focused on commercializing products for niche markets. Our client seeks opportunities to build its portfolio through acquisition of marketed or registration stage products and late stage development products that fit within its scope.
Opportunity Statement:
Our client's opportunity may appeal, in particular, to CRO CMC professionals seeking career growth by broadening their experiences working, directly, for a sponsor and those that may benefit from multi-asset exposure.
Key Responsibilities:
Led preparation of CMC related supplements to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologic License Agreements (BLAs).
Assist with compilation of CMC sections within Annual reports for NDAs, ANDAs and BLAs.
Provide regulatory assessment on internal and external change controls with a focus on CMC related changes.
Represent Regulatory Affairs on cross-functional product development/life-cycle management and manufacturing support teams.
Assist the Regulatory Affairs Team in formulating submission strategies.
Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory supplements and applications.
Assist with FDA inspections.
File agency correspondence in order to maintain complete regulatory files for each product.
Remain current with regulatory requirements and guidance documents.
Education:
BS, required. RAC Certification, preferred.
Experience:
Our client seeks 5 or more years of relevant experience in the Pharmaceutical industry with at least 2 years of specific experience related to regulatory submissions with focus on CMC.
Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
Knowledge of Common Technical Document (eCTD) and global guidelines on content.
Understanding of US federal regulations and processes related to the development of drugs and filing of an application.
Core Competencies:
Strong presentation skills, negotiating skills and influencing capabilities with external and internal clients.
Leadership of matrixed global teams.
Resilient to challenges while maintaining a positive can do attitude.
Energetic, results-driven with excellent organizational and prioritization skills.
Strong medical writer.
Demonstrated ethics and integrity.
Carlyle & Conlan actively recruits and refers applicants for all jobs without regard to race, religion, color, sex, age or national origin. As a professional search firm, we will only be responding to those inquiries that most closely align with the stated requirements. Moreover, our client employer can only review candidates with valid US work authorization at this time.
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