Bachelor's, Master's, or Ph.D. in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
5-7 years of regulatory affairs CMC experience in the pharmaceutical industry.
Expertise in preparing CMC sections for regulatory submissions and interacting with health authorities.
Strong understanding of global CMC regulatory requirements and ICH guidelines.
Excellent communication, collaboration, and project management skills.
Proven ability to prioritize and manage multiple projects in a dynamic environment.
Detail-oriented with a strong focus on quality and compliance.
Responsibilities
Lead the preparation and submission of CMC sections for various regulatory filings to health authorities.
Provide regulatory guidance to cross-functional teams throughout the product development lifecycle.
Interpret regulatory requirements and ensure alignment with global strategies.
Identify regulatory risks and recommend strategies to optimize outcomes.
Collaborate with internal stakeholders to maintain compliance and align with business objectives.
Establish relationships with regulatory agencies and represent the company in meetings.
Stay updated on emerging regulatory trends and assess their impacts.
Benefits
Comprehensive health insurance options.
Opportunities for professional development and training.
Flexible working hours and remote work options.
Collaborative and inclusive work environment.
Potential for career advancement in a growing company.
Full Job Description
Responsibilities:
Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes.
Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives.
Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.
Requirements:
Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
Detail-oriented mindset with a focus on quality, accuracy, and compliance.
Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
