Regulatory Affairs Specialist Job

Regulatory Affairs Specialist is needed to perform the following duties:

• Work under the guidance of regulatory affairs manager/senior regulatory affairs scientist to analyze scientific/medical information such as individual case safety reports (ICSR), aggregate drug safety reports, formulation data, material specifications, test methods and their respective spectra and prepare scientific/medical documents/reports for regulatory submissions as per US FDA guidelines and other International cGMP norms;
• Research scientific/medical/technical databases such as approved drug products with therapeutic equivalence evaluations, bioequivalence recommendations, FDA recommended dissolutions methods, inactive ingredient searches etc. as per instructions from department head & draft reports to analyze constantly changing/updated regulatory information to determine acceptability of data, procedures and other product-related documentation presented in support of product registration;
• Work in a group setting with senior regulatory team/pharmacovigilance scientists to coordinate with product development/marketing teams on regulatory requirements/strategies for development and approval of new and generic drug products;
• Draft ANDA submission documents containing technical/clinical/medical/scientific data on a routine basis for review, correction and approval by senior regulatory team members so as to enable timely completion of regulatory projects and submissions of documentation to regulatory agencies;
• Draft additional information/responses as requested by regulatory agencies under guidance and instructions from experienced regulatory/research team scientists & managers;
• Work in a group setting with experienced regulatory scientists and other departmental scientists/chemists to ensure compliance with relevant regulations and standards by analyzing product/process changes and deviations from FDA/regulatory commitments;
• Follow regulatory & established guidelines to review adverse drug reactions by analyzing ongoing safety surveillance & signal detection efforts and by identifying, assessing, documenting and communicating potential safety signals. Will collaborate with clinical research scientists and vendor clinical technicians who provide medical monitoring support for clinical trials and prepare scientific documents for regulatory submissions;
• Work in a group setting with experienced regulatory scientists to review labeling (that includes scientific/medical data), advertising and promotional labeling to ensure compliance to FDA/regulatory-approved brank labels, policies and guidelines;
• Follow established policies/instructions and assist regulatory manager/team draft and maintain regulatory documents/filings as per requirements. Maintain knowledge of current/changing regulations/guidelines/standards by researching scientific/medical publications as instructed and assist in coordinating with external regulatory/clinical teams; and
• Approximately 85% of the time will be spent in analyzing, researching, reviewing, coordinating, maintaining and drafting scientific/medical/technical data/reports for maintaining regulatory guidelines and for submissions to regulatory agencies – all under close supervision and guidance from experienced regulatory scientists (pharmacovigilance) & regulatory affairs manager. Approximately 15% of the time will involve interacting with regulatory agencies, outside clinical/scientific consultants, regulatory teams etc.

Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science.