Regulatory Affairs Associate, DENMARK - Talent Pool

Parexel is currently seeking a Regulatory Affairs Associate to join us in Denmark. As a Regulatory Affairs Associate you will be responsible for specified product portfolio. This product responsibility includes bothnational and central licenses and also projects still in development. You will act as a Subject Matter Expert and/or Key User for one or several expert areas within regulatory department. Be the regulatory expert providing regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.

Job Responsibilities Prepare and submit relevant regulatory submissions of high quality and in compliance with local regulatory requirements, in a timely manner. Ensure effective interaction with authorities to support local/central functions for assigned activities. Respond to questions from the authority in collaboration with the Headquarter. Ensure local labelling (SmPC, PIL, pack-label and compendium) are updated and consistent and comply with local regulatory requirements. Ensure pack artwork is updated according to local legislation and internal processes. Ensure local translations of high quality that are agreed with internal partners, according to SOP, and delivered according to timelines.

Initiate update of the regulatory databases in a timely/regular manner to ensure compliance. Keep fully aware of local and EU regulatory requirements and Internal Regulatory Processes and Policies Build/maintain local/central and external relationships to support assigned product portfolio and expert area. Provide regulatory input (also including environmental aspects) to the tender process (where applicable) for assigned portfolio. Participate in central project groups, when relevant, to ensure an optimal regulatory strategy is implemented. Work with supply and business to mitigate consequences of stock-out situations.

Represent regulatory function in cross-functional teams Participate in SOP maintenance and management monitoring activities as necessary. Knowledge, Competence And Skills University degree in a scientific area Initial years of Regulatory Affairs experience Good attention to details Able to take responsibility and provide leadership Collaborative approach and enjoy working in a team Able to influence and to liaise with internal and external stakeholders Understands both business content and issues in the external environment Fluent in English and local language