Regulatory Affairs Specialist - Submission Management

Reposted 5 Days Ago
Be an Early Applicant
2 Locations
In-Office
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
The Regulatory Submission Manager leads eCTD submissions, ensuring compliance with regulatory agency requirements. They collaborate effectively with stakeholders and manage submission processes, using tools like MS Office and Veeva Vault.
Summary Generated by Built In

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Your Opportunity

Operational Excellence

  • Ability to execute tasks like document formatting /quality checks /tracking/ publishing/ compiling with supervision while learning project planning and management basics.

  • Demonstrates potential to build trustful relationships with colleagues and stakeholders to support submission processes through communication and basic coordination.

  • Works effectively within a team by participating in collaborative efforts, contributing ideas, and asking for help as needed to achieve common goals.

  • Strong commitment to learning and adapting with guidance, including acquiring familiarity with new systems, tools, and workflows to foster personal and professional growth.

Who You Are

eCTD Expertise

  • Foundational understanding of eCTD submission format and regulatory requirements, with a focus on learning NMPA-specific guidelines and terminology in parallel to those of ICH, FDA, EMA, etc.

  • Familiarity with documentation assembly and formatting, working under supervision to gain practical experience in eCTD compilation and validation.

  • Essential knowledge to eCTD publishing processes, submission software, document management systems, and MS Office and Adobe Acrobat for document preparation; exposure to systems like RIM/Veeva Vault as part of training.

  • A proactive, motivated learner eager to understand regulatory changes and contribute to process improvement under guidance.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Skills Required

  • B.S. or above in Pharmacy, Medical, Biology or related field
  • 3 years' experience in Pharma MNCs, with at least 2 years in regulatory submissions
  • Experience in delivering eCTD submissions
  • Proficiency in Chinese and English
  • Good computer skills/information management skills

Roche Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.

  • Retirement Support U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
  • Leave & Time Off Breadth Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
  • Healthcare Strength Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.

Roche Insights

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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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