This role will be responsible for regulatory work related to submission of the ANDA/NDA/BLA/IND to FDA under the guidance of other senior members of the team along with distribution quality assurance support to the group.
· Compilation, review (as needed) and submission of the regulatory correspondences related to ANDA/NDA/IND/BLA to FDA through ESG.
· Support to logistics and supply chain via review of work instructions, assessment of temperature data, damaged consignments and review of case label and pallet labels. Promotional materials review as per the need.
· Assist in all Regulatory Affairs department activities, including electronic publishing, regulatory intelligence, product labeling updates, and adverse event processing.
· Archive and maintenance of product submissions and FDA correspondence.
· Assist in the development of departmental SOPs as required.
· File, organize and retrieve submissions related documentation from regulatory archives.
· Maintain spreadsheets and tracking systems as required. Update and maintain templates and SOPs for regulatory submissions.
· Aid regulatory affairs team in activities such as cover letter and form preparations associated with regulatory submissions.
· Facilitate payments needed for submissions, establishment registrations, export certificates, consultants, purchase of supplies and other regulatory activities.
· Any additional responsibilities as assigned by hiring manager.
· Maintain regulatory databases to ensure accuracy of information
Maintain current knowledge of regulations and other issues that affect products and industry.
· Bachelor’s Degree in a scientific area
· 2-3 years of pharmaceuticals experience, that includes technology, communication, organization, time management and planning skills.
· Strong organizational skills with the ability to keep others organized and meet all deadlines
· Demonstrated ability to learn & process new information quickly
· Robust communication and analytical skills.
· Attention to detail and quality
· High degree of demonstrated proficiency with Excel, Word and PowerPoint
· Ability to shift priorities and change directions frequently throughout the day
· Ability to work with multiple top priorities, and requests from Sales and Marketing
· Advanced computer skills & ability to conduct research through the internet