Regulatory Affairs Submission Manager Viseu

Regulatory Affairs Submission Manager
Viseu
Viseu, Viseu District, 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 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 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
  -
  - 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
- 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.