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 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