Regulatory Affairs Submission Manager

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 Submission Manager to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture.

Job description (main tasks) :

Initiating, coordinating and supervising the registration of medicinal products through European procedures (MRP, DCP, CP) or national submissions across all regions of interest

Devising submission strategy for each project, in line with all applicable requirements, and assign due dates

Directing and coordinating preparation of document packages for regulatory submissions, in line with the in force European regulations and / or local pharmaceutical laws depending on the submission type and market

Ensuring that all responses to authorities’ requests are correct, complete and timely provided

Communicate with third parties to expedite submissions and ensure regulatory compliance

Ensure that all the additional processes related to national submissions (pre-reviews, DMF, PMF, GMP accreditation etc.) are provided on time and that their submission / approval process does not delay the application

Ensure that accurate and complete information is timely provided to other departments / third parties

Provide support for samples preparation and dispatch, when necessary

Inform the relevant functions on the status and progress of assigned projects to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur

Compile, verify and publish submissions using electronic publishing software considering the submission deadlines and technical requirements on management of dossiers lifecycle

Documenting and tracking regulatory related processes within the organisation

Ensure that the internal trackers and dedicated templates are kept up-to-date

Perform regular reviews of the information available on the internal SP

Candidate Requirements :

5+ years of experience in regulatory affairs with a focus on submissions .

Strong knowledge of ANVISA regulations and other health authority requirements.

Ability to work effectively without direct supervision and to be able to report succinctly and efficiently

Skills :

Excellent communication skills in Spanish, and English.

Computer skills : very good knowledge of MS Office tools

Project management capabilities, including but not limited to creation of timelines, organization of meetings, meeting minutes, planning and execution

Solution oriented working skills

Attention to details

Ambitious, responsible person

Enthusiastic, proactive

Teamwork spirit, also able to perform alone

Analytical thinking, problem solving capacity

Well organized

Good communication skills

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.