Job Title:
Regulatory Affairs Specialist
About the Role:
The Regulatory Affairs Specialist will play a crucial role in ensuring compliance with local regulations and quality system requirements. This individual will be responsible for managing all aspects of regulatory affairs, including supervising the Regulatory Affairs Department, fostering an environment of operational excellence, and facilitating external relationships with government bodies and industry associations.
Responsibilities:
* Develop and implement the regulatory plan and strategy in alignment with affiliate business plans as well as regulatory requirements.
* Ensure submission and approval of high-quality regulatory applications within planned timelines.
* Prepare and support new applications to obtain marketing authorizations.
* Voicing affiliate perspective and needs to global and regional regulatory contacts.
* Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
Requirements:
* Bachelor's degree or equivalent in a relevant scientific subject.
* At least one year industry-related experience in regulatory affairs and experience of dealing with external regulatory agencies, the healthcare system, and marketing needs.
* Team working skills with special focus on results.
* Ability to adapt to challenging situations.
* Demonstrated good computer/IT skills.
* Good knowledge of written and spoken English.
What We Offer:
* Travel expected (less than 10%).
* Flexible hybrid working options.
* Healthcare, pension, and life assurance benefits.
* Subsidised canteen, onsite gym, travel subsidies, and on-site parking.
Our Culture:
We are committed to diversity, equity, and inclusion (DEI). Our culture is built around four pillars: EnAble, embRACE, LGBTQ+, and Ally, and Gender Inclusion Network. We cater for all dimensions, ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender.