Regulatory Affairs Submission Manager Lisboa

Regulatory Affairs Submission Manager
Lisboa
Lisboa, Lisboa, Portugal

At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver
- 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 for LATAM and/or Brazil to join our dynamic Adalvo team. This position offers an opportunity to
- suited candidates to join a growing, fast paced energetic environment and culture.

Job description (main tasks):

Initiating, coordinating and supervising regulatory submissions for pharmaceutical products in Latin America (LATAM) region and Brazil

Ensuring submissions compliance with ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), ISP (Chile), DIGEMID (Peru ), and other LATAM regulatory authorities.

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

Tracking and managing submission timelines, proactively identifying and addressing potential delays

Directing and coordinating preparation of document packages for regulatory submissions,

in line with local pharmaceutical laws

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

Providing support for samples preparation and dispatch, when necessary

Informing 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

Documenting and tracking regulatory related processes within the organisation

Ensure that the internal trackers and dedicated templates are kept
-
- 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 in LATAM & Brazil.

Strong knowledge of ANVISA regulations and other LATAM health authority requirements.

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

Skills:

Excellent communication skills in Portuguese, 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
- 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.