The Regulatory Affairs Manager is responsible for development of efficient registration of NAH products in his/her area of responsibility as well as ensuring regulatory compliance of approved products.
Responsible for Agency relations by maintaining close contacts to the relevant authorities. Responsible for thorough understanding of Canadian requirements and in the turntable function has general understanding and knowledge of regulatory requirements for all countries supported. Competent authority interactions may range from written communications to in-person meetings within the scope of responsibility. Understanding of regulatory agency interactions and influences.
Responsible for ensuring professional planning, competent RA input, efficient registration and maintenance of the registrations of existing marketing authorizations in accordance with business needs, directions and strategies. Plan, direct and coordinate all regulatory activities of the assigned products or areas of responsibility (e.g., CMC) in collaboration with (according to applicability): country regulatory professionals, local CBU, project teams, and/or competence centre regulatory professionals, ensuring successful implementation, follow through and completion of tasks.
Prepare, write and review Part 2/CMC documents (e.g., detailed and critical summaries, tabulated summaries) for products in development to be newly submitted globally and for any post-approval submission, according to the latest regulatory requirements of the focus countries.
Lead and coordinate the technical documentation process and ensure that the required CMC documents are generated to the appropriate quality by advising technical managers authoring them.
May lead regulatory sub-teams as part of the International Project Teams if a competence centre professional. Lead local teams and participate on cross-functional teams.
Ensure regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submissions and strict participation in the global/local change control operations. Ensure regulatory compliance by timely submission of variations.
Apply procedures and systems necessary to maintain proper records and support adequate controls.
Perform other related duties and assignments as required by the business and directed by management.
Advise business and provide guidance/direction on regulatory matters, making recommendations and giving direction considering current and future trends.
Participate and represent RA and NAH in various teams, trade associations and professional organizations.
May lead work groups in trade associations with intent of influencing regulatory agency and policy Minimum requirements Education: Advanced degree in life sciences such as veterinary medicine, toxicology, pharmacy, chemistry or other comparable qualifications.
Minimum 2 years of experience, with advanced degree, in regulatory affairs, preferably animal health, combined with knowledge in product development or equivalent experience.
Experienced project team leader with matrix/multidisciplinary teams, demonstrated communication skills both verbal and written, the ability to work autonomously, an awareness of global needs/requirements.
Experience with developing and building talent.
Knowledge of PC package tools: Word and Excel required; knowledge of data management systems and publishing tools beneficial.
Ability to set priorities, manage multiple tasks, identify solutions to problems/pre-emptive behavior, able to evaluate and assess risk.
Accountability; Technical Expertise & Application; Problem solving and innovation, Collabortaion and influencing people; Leadership; Regulatory affairs expertise and neotiation/communication skills. Novartis - 10 months ago