At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo !
We are looking for an enthusiastic Regulatory Affairs Specialist, CMC to join our dynamic Regulatory Affairs team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.
SUMMARY OF POSITION
The Regulatory Affairs Specialist (CMC) has the responsibility of supporting the activities to secure and maintain marketing authorizations in target markets. The Regulatory Affairs Specialist will act as a reference point in regulatory matters.
ORGANIZATION STRUCTURE
This role will report directly to the Senior Director of Regulatory Affairs CMC.
RESPONSIBILITIES
Evaluate and assess marketing authorization application dossiers.
Compile dossiers for presentation to regulatory authorities.
Support technical transfers.
Contribute to regulatory lifecycle management.
Compile technical documentation in relation to medical devices
QUALIFICATIONS & REQUIREMENTS
Attention to detail, flexibility, and the ability to adapt quickly to changing requirements.
Communication, organizational and project management skills are essential to coordinate multiple activities, often with competing priorities
Minimum of a bachelor's degree in science (example pharmacy, pharmaceutical technology, chemistry, etc.).
Applicant must have a minimum of 4 years experience in a similar role within the pharmaceutical industry
CORE COMPETENCIES
Target Driven
Attention to details
Ambitious, responsible
Enthusiastic, proactive
Teamwork spirit, also able to perform alone
Analytical thinking, problem solving capacity
Well organized
Good communication skills
Optimistic
Why join us?
Exciting Challenges: Every day brings new opportunities to learn and grow.
Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.
Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.
Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.
Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.
Ready to Ignite Your Passion?
If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!
Please be informed that only selected candidates will be contacted.