The Sr. Associate of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) position is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. Ensures effective communication with all the key departments within Meitheal and global Regulatory Affairs in support of regulatory filings.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while being in compliance with all regulatory requirements.
• Preparation and review of US FDA submissions, including original NDAs and ANDAs, and amendments, supplements, annual reports, labeling changes to NDAs and ANDAs.
• Reviews documentation from partners both domestic and international for technical and regulatory compliance.
• Represents the Regulatory Affairs department in project development meetings and assists in the development of regulatory strategies.
• Provides regulatory assessments to the company (internal and partners) and implements change controls and/or document changes based on ICH and FDA guidelines.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Assimilate to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated.
• Have a sense of urgency to meet all required deadlines.
Education and/or Experience:
• Bachelor's degree in life sciences from a 4-year college or university; a minimum of 2 years related experience and/or training; or equivalent combination of education and experience.
• Experience in Pharmaceutical R&D and/or Manufacturing setting with some exposure to Regulatory Affairs is highly preferred.
• Strong written and communication skills.
• Experience communicating with global teams is preferred.
• Ability to handle multiple projects concurrently.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.