Job Title Regulatory Affairs Associate - Authoring Role detailed classification Regulatory Affairs Authoring Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - Authoring to join our LS Practice team The successful candidate will be responsible for LS Regulatory Authoring and or other assigned RA activities The role will involve knowledge of Global Regulatory Affairs guidelines platforms and systems to undertake various assigned roles and responsibilities included but not limited to below described activities A Life Sciences Regulatory Writer is responsible for preparing high-quality documentation required for regulatory submissions of drugs biologics medical devices or combination products These professionals play a key role in translating complex scientific data into transparent compliant and compelling regulatory documents The writer ensures that all documentation complies with global regulatory standards and supports submissions to agencies like the FDA EMA and other health authorities Key Responsibilities Life Sciences Regulatory Affairs Associate plays a crucial role in ensuring compliance within the pharmaceutical medical devices and biotechnology industries by managing the assigned regulatory affairs activities for regulatory submissions health authority queries approvals variations renewals licence maintenance regulatory compliance throughout the product lifecycle This role involves preparing writing and reviewing regulatory documents maintaining compliance with global standards and regulations and utilizing Regulatory systems to track and organize critical data for various assigned activities Specific to Regulatory Authoring 1 Dossier Preparation and Submissions Authoring Preparing finalizing CMC Safety sections for various regulatory submissions including drug master files DMFs EU MDR CE Marking FDA 510 k PMA INDs NDAs BLAs MAAs ANDAs and or CTAs and other documentation as per the current requirements of