SRS’ finished formulations focus on highly-valued drugs and complex formulations around, incorporating novel drug delivery systems to enhance compliance and improve efficacy.
The role of Regulatory Affairs Manager focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives; Maintaining regulatory compliance of products for the following regulatory activities: initial, renewal, variations, promo permits, marketing materials, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity.
As part of a global team, active participation in cross-functional teams (Supply Chain, Marketing, Medical Affairs & QA) within the company is a critical part of this role. The provision of regulatory expertise and insight as well as updates on current local regulations and potential changes that will impact the business environment is a fundamental part of the role and as such good communication skills and proactiveness are highly prized.
Familiarity and experience with pharmaceuticals, therapeutic areas such as oncology, food products and other hospital/healthcare practices.
Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications and Power Point.
Substantial experience in and understanding of role of RA and regulatory requirements in Life Sciences Industry including ICH requirements and regional requirements and understand current trends in the local market.
Good project management skills with the ability to prioritize and multi-task.
Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.
Flexible “can do” attitude needed to thrive in an ambitious and fast-growing company.
Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
Good communication skills, especially as it relates to transparency, collaboration and ability to work across communication channels.
Self-motivated, able to work independently, enjoys a good challenge and remains focused even in the face of setbacks.
Flexible, determined, eager to experiment and has an open mind.
An independent and reliable way of working; Takes initiative and ownership.
High levels of integrity and honesty.
BA/BS/University degree required, Life/Health Sciences preferred.
Typically requires a degree in a scientific field and/or master in regulatory affairs and Degree in a scientific field is preferred.
Minimum 5-year experience in performing regulatory affairs responsibilities from the Pharma and/or Medical Device and/or Food Industry and/or food supplements and/or cosmetics, of which at least 2 years are performed in a supervisory/specialist level.
Experience in preparing a product dossier iaw ICH guidelines.
Experience of working on a e-dossier management system.