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Lead regulatory affairs specialist

Cork
beBeeRegulatoryAffairs
Regulatory affairs specialist
Posted: 7 July
Offer description

Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and guidelines for the development and approval of new products.


About the Role

This is an exciting opportunity to work in a dynamic environment where you will have the chance to develop and implement regulatory strategies to support product approvals. You will work closely with cross-functional teams to ensure that all aspects of product development and commercialization are aligned with regulatory requirements.


Responsibilities

* Develop and implement regulatory strategies to support product approvals
* Ensure compliance with regulatory requirements and guidelines
* Collaborate with cross-functional teams to ensure alignment with regulatory requirements
* Communicate effectively with regulatory agencies and stakeholders
* Liaise with internal teams to resolve regulatory issues and provide guidance


Requirements

To be successful in this role, you will need to have:

* A degree in a scientific or health sciences discipline
* Industry-related experience in regulatory affairs and/or drug development
* Strong knowledge of FDA and Health Canada procedures and practices
* Excellent written and verbal communication skills
* Ability to work in a fast-paced environment and meet deadlines


What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. Our team is passionate about making a difference in people's lives, and we are looking for someone who shares our values and is committed to excellence.

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