Expert for RA Pharma Safety & Efficacy - ALKU


: $123,610.00 - $159,420.00 /year *

Employment Type

: Full-Time


: Pharmaceutical/Biotechnology

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Job Description: Act as RA core- or subteam member in projects as well as in program teams. Anticipate changes in pertinent regulations and evaluate impact on projects/existing products. Define sound regulatory strategies for assigned products/projects within the team and ensure regulatory compliance with regards to safety and efficacy. The position will link the safety and efficacy regulatory team with internal stakeholders and external stakeholders (regulatory agencies) to ensure comprehensive synergies between regulatory, research, development and business activities in accordance with the strategic plan of the company. Duties: Responsibility for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable. Responsibility for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects. Requirements: At least 5 years in Regulatory Affairs positions, or equivalent in the pharmaceutical industry. Must include a minimum of 2 to 3 years conveying exposure to authorities (e.g. in new product development or complex maintenance projects, leadership of RA subteams). Sound knowledge of the legal requirements for approval of veterinary medicinal products. Knowledge in international product registration and/or product development is desired. . Awareness of the industry/direct competitor's activities.

Associated topics: biomedical, clinical, drug, drug development, healthcare, industrial hygienist, medical, pharmaceutical, toxicologist, trauma * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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