Automotive Project Quality Engineer GL703

Descripción del trabajo

We are looking for an International Regulatory Affairs & Partnerships Global Lead for an international pharmaceutical company specialized in skincare.

Main Responsibilities:

1. 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.
2. 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.
3. Collaboration with Health Authorities and RA & Trade Associations: Act as the point of contact with health authorities globally at a policy level.
4. 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.
5. Risk Management: 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:

1. Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, or a related field.
2. Minimum of 5-7 years of experience in regulatory affairs, preferably in an international setting.
3. Strong knowledge of global regulatory requirements at Global Level (EU, Andean, USA, China…).
4. Proficiency in regulatory software and tools.
5. Multilingual abilities are an advantage.
6. Excellent communication, negotiation, and leadership skills.