The position will be responsible for:
Preparation of US labelling documents. Ensuring compliance with packaging regulations and internal standards.
Managing activities related to cross-functional projects related to US packaging and product information.
Preparation (markup/annotate and clean) packaging components for the US region.
Perform the review and approval activities for US packaging components through appropriate repository.
Proofread labeling, including SPL, (during all phases of submission and post-approval process) to ensure the labeling conforms to regulations and guidelines.
Provide annual reportable changes for US products to the FDA.
Assist in audits/inspections.
Project management opportunities.
Performs other regulatory labelling duties as required (e.g., document preparation for regulatory inspections).
5-10 years experience in Pharmaceutical Industry (e.g. Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance).
Good understanding of the pharmaceutical industry, drug development environment, Research & Development and maintenance processes and objectives.
Working knowledge of pharmaceutical regulations and requirements, Health related regulations
Knowledge of the labelling environment and regulations
Strong interpersonal skills to motivate the team and liaise effectively with internal and external contacts
Ability to communicate effectively and efficiently with other functional departments in the business
Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
Ability to work with multifunctional and multicultural teams and in a matrix organization.
Experience with proofreading tools (i.e. TVT, DocuProof)