Regulatory Affairs - Executive/Assistant Manager/Deputy Manager/Manager

As an experienced professional in the pharmaceutical industry, you will be responsible for authoring, writing, and reviewing CMC sections of dossiers. Your critical review skills will be essential in examining design stage documents such as specifications, controls, and protocols to ensure compliance with regulatory requirements. You will play a key role in assessing change controls to determine their regulatory impact and develop strategies for post-approval submissions. Coordinating the collection of post-execution data from different functions and reviewing them against design specifications will be part of your daily tasks. Collaboration with cross-functional team members will be crucial for the timely resolution of action items identified to address deficiencies. Your attention to detail will be required to review the accuracy of information in various status reports and databases maintained at the department or organization level. Ensuring regulatory submissions comply with current regulations and guidance will be a top priority. Whether contributing individually or managing a team, you will be instrumental in achieving timely target submissions. Additionally, you will be involved in training and developing individuals to help them reach department and organizational objectives.,