Regulatory Affairs Manager

Madrid - Spain

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

In a nutshell

Position: Regulatory Affairs Manager
Location: Madrid (on-site)
Experience: 5 years in Regulatory Affairs within biotech/biopharma

Want to know more

BioNaNopharma is a leading biotechnology company committed to innovation and the sustainable development of advanced pharmaceutical solutions. Our multidisciplinary team is dedicated to the development manufacturing and commercialization of innovative medicines and biosimilars making a real impact on global health.

Ready to be a #Challenger at BioNaNopharma

What are we looking for

We are seeking a Regulatory Affairs Manager to lead the regulatory strategy for our innovative and biosimilar products ensuring compliance and collaborating with global cross-functional teams.

Key Responsibilities:

Monitor changes in the regulatory landscape identify impacts and propose solutions to maintain compliance.
Define regulatory strategy for each product in coordination with Management and Business areas.
Build strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety.
Identify and mitigate regulatory risks adapting strategies to evolving regulations and Health Authority feedback.
Interpret and communicate legislative changes affecting product registration manufacturing or development.
Support the review of license and quality agreements for targeted geographies.
Lead engagement with Health Authorities during Scientific Advice procedures and responses to deficiency letters.
Prepare review and approve regulatory submission documents (briefing packages IBs INDs CTAs MAAs etc.).
Manage external consultants and vendors in regulatory activities.
Support product launch activities and ensure regulatory risks are managed with appropriate action plans.
Organize the regulatory submission schedule and coordinate with Regulatory Affairs teams.
Participate in product plan development regulatory strategy and CMC documentation.
Drive digitalization and the use of computerized systems within the department.

The challenge!

Oversee the preparation and submission of regulatory documentation.
Coordinate regulatory strategy with R&D QA QC and Production teams.
Lead negotiations and presentations with regulatory agencies.
Manage regulatory information and ensure data integrity.
Actively participate in scientific committees and project teams.

What do you need

Degree in Health Sciences (preferably Pharmacy but also Chemistry Biology Biochemistry Veterinary or similar).
5 years of experience in Regulatory Affairs within biotechnology biopharma or biosimilars.
In-depth knowledge of pharmaceutical legislation GMP and ICH guidelines.
Fluent in Spanish and English (other languages are a plus).
Advanced proficiency in office tools (Word Excel PowerPoint Project) and regulatory software.
Willingness to travel.
Inspiring influential results-oriented and excellent communication skills.

Our benefits!

Permanent contract

Professional development and continuous training

International and multidisciplinary environment

Innovative projects with high impact on health

Whats the selection process like

Initial contact by phone or email.
1-2 interviews (virtual and/or on-site) with HR and technical teams.
Ongoing communication about your application status.

Not the right fit for you

#BioNaNopharma #Challenger #RegulatoryAffairs #BiotechTalent

COMMITMENT TO EQUAL OPPORTUNITIES

At BioNaNopharma we promote gender equality and do not discriminate based on ethnicity religion sexual orientation disability or any other condition. We believe diversity and talent drive innovation and growth.

Required Experience:

Manager

In a nutshell Position: Regulatory Affairs ManagerLocation: Madrid (on-site)Experience: 5 years in Regulatory Affairs within biotech/biopharmaWant to know more BioNaNopharma is a leading biotechnology company committed to innovation and the sustainable development of advanced pharmaceutical solution...