Senior Advisor for Regulatory Compliance
1 month ago
About ProPharma Group
For over two decades, ProPharma has been dedicated to enhancing patient health and wellness by delivering expert guidance that empowers organizations in the biotech, medical device, and pharmaceutical sectors to confidently progress scientific innovations and launch new therapies. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate model that spans the entire product lifecycle.
Position Overview
ProPharma Group is seeking to expand its Regulatory Affairs Division by adding a Senior Regulatory Consultant. This role can be performed from various locations.
Key Responsibilities
In the capacity of Senior Regulatory Consultant, you will engage in diverse projects for a range of pharmaceutical clients. Your role will involve:
- Engaging in Regulatory Affairs with a primary focus on local operations, particularly within the Nordic region.
- Managing new registrations, variations, and marketing authorization holder transfer applications.
- Maintaining regular communication with health authorities.
- Conducting regulatory intelligence assessments.
- Providing local regulatory guidance.
- Preparing for product launches.
- Offering strategic and operational regulatory support to clients and team members.
- Conducting regular follow-ups with clients regarding project status and quality.
- Collaborating with other service lines within the organization.
Qualifications
The ideal candidate will possess:
- A solid understanding of registration processes and product lifecycle management from a regulatory perspective.
- The ability to recognize customer needs and adapt accordingly.
- Strong problem-solving skills, with a pragmatic and proactive approach to meeting deadlines.
- A keen attention to detail while maintaining focus on overarching project goals.
- Excellent communication skills in both Swedish and English; proficiency in another Nordic language is advantageous.
- A minimum of 5 years of experience in Regulatory Affairs, with a focus on Nordic regulations.
- A Master’s degree in Pharmacy or an equivalent qualification.
Diversity and Inclusion
At ProPharma, we celebrate diversity and are committed to fostering an inclusive workplace where every individual can express their authentic self. We encourage our employees to unleash their innovative, collaborative, and entrepreneurial spirit. As an Equal Opportunity Employer, we provide a supportive environment where all team members are empowered to thrive.
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