The Regulatory Submissions Manager is responsible for ensuring that processes related to the filing of applications and related correspondence to relevant government authorities are completed in a timely and accurate manner in accordance with applicable regulations.
Essential Job Functions
Develop and revise SOPs and Work Instructions that govern Regulatory Submissions.
Manage the timely and accurate submission of regulatory filings, including INDs, NDAs, ANDAs, supplements and amendments, annual reports, CMC sections for customers, suitability petitions and other correspondence as requested by the FDA.
Identify, obtain, and track a quantity of reference drugs sufficient for use in product development and for retention samples.
Oversee the timely and accurate preparation of Annual Product Reviews.
Maintain current knowledge of FDA and ICH guidelines, monitor changes and track regulatory developments relevant to the development and application process. Serve as a regulatory resource for all units within the company.
Review and approve various reports and documents generated in support of company operations, that support regulatory filings.
Audit procedures and related documents for accuracy and compliance with guidelines and regulations.
Communicate effectively with project management the current review status and effectively resolve any issues related to unapproved filings.
Participate as Regulatory representative on cross-functional teams.
The individual selected for this role must be independent and will require to get things done through soft project management, only resorting to issue escalation when completely necessary.
A Subject Matter Expert able to provide clear guidance and direction.
Effective team worker in a matrix team.
Reliable, driven, and organized.
Strong attention to detail, and results oriented.
Excellent communication skills (oral and written).
Flexible work hours.
The Regulatory Submissions Associate(s) will report to the Manager of Regulatory Submissions.
Education and Qualifications
Bachelor’s degree in a scientific/technical discipline with at least 7 years’ experience in a regulatory position in the pharmaceutical industry and at least 3 years in a quality or regulatory leadership role.
Successful completion of multiple U.S. regulatory submissions (e.g., NDAs, ANDAs).
Highly knowledgeable of FDA regulatory requirements applicable to Oral Dosage or pharmaceuticals. Ability to apply GMP regulations and other FDA guidelines to all aspects of the position.
Mastery of the English language and excellent communication oral and written skills are required.
Experience with computer systems, particularly Microsoft Office and Adobe Acrobat, and basic typing skills are required. Experience with MedXView is preferred.
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
Walking, sitting for long periods, and repetitive hand motions.
Occasional lifting or moving required.
This role will be based in Atlanta and minimal travel will be required.
Internal Number: REG-19-00001
About Mikart, LLC
Mikart is a recognized leader in providing contract services for the development and manufacture of quality pharmaceutical products from formulation development through full-scale commercial production. Located in Atlanta, Georgia, the company offers product development, analytical services, manufacturing, packaging and regulatory services for solid dose and non-sterile liquid prescription drug products.
We are one of the premier contract pharmaceutical R&D and production operations in the US. The hallmark of our reputation since 1975 is our ability to respond quickly and address challenges to keep our customer’s projects moving forward and to provide the highest quality product.
Mikart’s employees are fundamental to the foundation of our success, and our staff plays an integral role in building longstanding and profitable customer relationships. We are committed to hiring and retaining high quality professionals.
Mikart offers an excellent benefits package from date of hire. The company fosters an open door management policy and building close-knit teams. We stress balance between our employee’s personal and professional life, and foster a friendly, yet professiona...l, work environment using advanced technology in state-of-the-art facilities. Continuous pursuit of improvement underscores all that we do.