Regulatory Affairs Submissions Manager

Adalvo; Almada; Presencial; EUR 90 000 - 120 000; Tempo integral

Resumo da oferta

Adalvo is seeking a Regulatory Affairs Submissions Manager - LATAM to lead regulatory submissions across LATAM markets, coordinating strategies and ensuring timely marketing authorisations.

The role reports to Regulatory Affairs Director, LATAM; requires 7+ years experience, LATAM submissions capability, and fluent Spanish and English. Caparica, Portuguese Republic, PT.

You will work with cross-functional teams, manage dossiers, and liaise with authorities to maintain compliant processes.

Qualificações

• At least 7 years Regulatory Affairs experience.
• Proven LATAM regulatory submissions capability.
• Spanish language advanced, English advanced.
• Experience with cross-functional teams and timelines.

Responsabilidades

• Initiating, coordinating and supervising the registration of medicinal products in LATAM markets.
• Coordinate and follow up on regulatory due diligence activities with cross-functional teams, ensuring timely assessment of dossier gaps, country-specific requirements, regulatory risks and feasibility for LATAM markets.
• Devising submission strategy for each project and partner, in line with all applicable requirements, and assign due dates
• Directing and coordinating preparation of document packages for regulatory submissions, in line with LATAM regulations and /or local pharmaceutical laws depending on the submission type and market
• Ensuring that all responses to authorities' requests are complete and timely provided
• Communicate with third parties to expedite submissions and ensure regulatory compliance
• Ensure that the related administrative documents (CPPs, GMPs, Manufacturing agreements, legalization, apostille, samples dispatch etc.) are provided on time and that their submission/approval process does not delay the application
• Interact with the project and functional teams to ensure that data generated is appropriate and will be compiled and submitted in accordance with LATAM requirements.
• 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
• Documenting and tracking regulatory related processes within the organization
• Ensure that the internal trackers and databases are kept up-to-date

Conhecimentos

LATAM submissions

Spanish (advanced)

English (advanced)

Regulatory affairs

Project management

Descrição da oferta de emprego

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, fast and always on target, we are Adalvo !

We are looking for an enthusiastic Regulatory Affairs Submissions Manager - LATAM to join our dynamic Quality 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 Manager LATAM is responsible for the planning, coordination, and timely delivery of regulatory submissions across Latin American markets. The role ensures effective execution of registration, including dossier gap assessments, country-specific adaptations, coordination of regulatory documentation and follow-up of regulatory procedures until Marketing Authorisations are granted.

The person responsible also plays an active role in generating regulatory strategies, identifying regulatory risks and opportunities, and ensuring successful implementation of regulatory plans across LATAM markets.

ORGANIZATION STRUCTURE

This position will report to Regulatory Affairs Director, LATAM

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Initiating, coordinating and supervising the registration of medicinal products in LATAM markets.
• Coordinate and follow up on regulatory due diligence activities with cross-functional teams, ensuring timely assessment of dossier gaps, country-specific requirements, regulatory risks and feasibility for LATAM markets.
• Devising submission strategy for each project and partner, in line with all applicable requirements, and assign due dates
• Directing and coordinating preparation of document packages for regulatory submissions,

in line with LATAM regulations and /or local pharmaceutical laws depending on the submission type and market

• Ensuring that all responses to authorities' requests are complete and timely provided
• Communicate with third parties to expedite submissions and ensure regulatory compliance
• Ensure that all the related administrative documents (CPPs, GMPs, Manufacturing agreements, legalization, apostille, samples dispatch etc.) are provided on time and that their submission/approval process does not delay the application
• Interact with the project and functional teams to ensure that data generated is appropriate and will be compiled and submitted in accordance with LATAM requirements.
• 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
• Documenting and tracking regulatory related processes within the organization
• Ensure that the internal trackers and databases are kept up-to-date

QUALIFICATIONS & REQUIREMENTS

• At least 7 years Regulatory Affairs experience
• Proven LATAM regulatory submissions capability is mandatory
• Previous hands-on experience managing regulatory submissions across Latin American markets
• Knowledge of ANVISA requirements and previous experience with Brazilian submissions is desirable
• Spanish language: advanced level, both speaking and writing;
• Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
• English language: advanced level, both speaking and writing;
• 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
• Work effectively with cross-functional teams

CORE COMPETENCIES

Ability to work effectively in a dynamic and fast-paced environment while managing multiple priorities

Target Driven

Ambitious, responsible

Teamwork spirit, also able to perform alone

Analytical thinking, problem solving capacity

Well organized

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!

Please be informed that only selected candidates will be contacted.

Regulatory Affairs Submissions Manager • Caparica, Portuguese Republic, PT