What are the responsibilities and job description for the Regulatory Affairs Associate position at Havix Group LLC?
Qualifications • Thorough understanding of the science and medical standards of care are essential • 1 years pharmaceutical or bio-tech industry experience • Ability to communicate highly scientific and technical medical information • Excellent communication / interpersonal skills / passion for excellence • Demonstrated leadership ability • Effective administrative / organizational skills • Ability to work independently and collaborative with internal teams fostering a culture of efficiency and teamwork • Adept at handling multiple projects and tight deadlines in a fast-paced environment • Strong quantitative analytical skills, including proficiency with Excel, PowerPoint (or equivalent) • Understanding of drug discovery / development and regulatory approval processes • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions • Must be able to sit for long periods of time • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear • The employee must occasionally lift and/or move up to 25 pounds • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices | Responsibilities • The Regulatory Affairs Specialist will report to the Head of Regulatory Affairs and work closely with other Aavis teams including but not limited to Commercial, Business Development, Clinical, Regulatory, Technical Operations, Legal, and Finance • Evaluate the established safety and efficacy profile of potential pipeline assets and FDA-approved product acquisition targets of strategic interest. • Evaluate the regulatory pathway for potential pipeline assets, considering the necessary safety and efficacy endpoints required for FDA approval • Generate and maintain competitive landscape analyses; summarize and present the analysis to help facilitate asset prioritization for business strategy decision-making • Assess the current standards of care within relevant therapeutic areas to provide insight on potential future investments needed to build the scientific platform for potential pipeline or product acquisition targets • Support the facilitation of medical information and scientific inquiries from health care practitioners, payer groups, formulary decision makers, key thought leaders, advocacy groups, medical societies, and internal stakeholders • Assist as needed with ongoing medical review of scientific, advertising/promotion materials, and grant requests • Utilize professional and clinical judgement to critically evaluate the scientific accuracy of manuscripts/publications, clinical studies, and outcomes research on Aavis and competitor medications • Support the Regulatory Affairs team in the management of several key programs/new initiatives within Regulatory Affairs, including medical communications/vendors, patient-focused materials, payer market materials, dossier development, or policies/SOPs • Educate/train/present key scientific medication and disease state information to internal (e.g., Sales, Marketing, Managed Care) and external stakeholders (e.g., health care practitioners, key thought leaders, advocacy groups, payers) for Aavis products • Assist with support of the Medical Science Liaison (MSL) staff and ongoing initiatives |