We are looking for an International Regulatory Affairs & Partnerships Global Lead for an international pharmaceutical company specialized in skincare.
Main responsibilities :
* Regulatory Compliance Management : Oversee and ensure compliance with global regulatory requirements for products and processes.
* Maintain up-to-date knowledge of international regulations and standards, including those specific to targeted regions and industries.
* Develop and implement regulatory strategies that align with corporate objectives.
Affiliate Management :
* Establish and maintain strong relationships with international affiliates to ensure alignment with regulatory standards.
* Provide guidance and support to affiliates in meeting local regulatory requirements.
* Monitor affiliate compliance and performance, addressing any gaps or risks proactively.
Collaboration with Health Authorities and RA & Trade Associations :
* Act as the point of contact with health authorities globally at a policy level.
Influencing and Driving Change :
* Influence and motivate affiliates to adopt and implement regulatory changes effectively.
* Conduct training sessions and workshops to build regulatory knowledge and capabilities across affiliates.
* Foster a culture of compliance and continuous improvement.
* Identify and assess regulatory risks and develop mitigation strategies.
* Monitor and analyze changes in regulatory landscapes, advising stakeholders on potential impacts.
* Collaborate with cross-functional teams to address regulatory challenges proactively.
Requirements :
* Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, or a related field.
* Minimum of 5-7 years of experience in regulatory affairs, preferably in an international setting. Strong knowledge of global regulatory requirements at Global Level (EU, Andean, USA, China…).
* Proficiency in regulatory software and tools.
* Multilingual abilities are an advantage.
* Excellent communication, negotiation, and leadership skills.
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