Regulatory Affairs Associate - Talent Pool
Denmark, Remote 职位编号 R0000034323 类别 Consulting关于这个职位
As a Regulatory Affairs Associate you will be responsible for specified product portfolio. This product responsibility includes both
national 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
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