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(Senior) Regulatory Affairs Manager

Employer
Novartis
Location
Beijing, China
Salary
Competitive
Closing date
Feb 1, 2023

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma

Job Details

Job Description

500+ Ongoing clinical trials; 160+ Projects in clinical development; 80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
•Provide regulatory inputs in new project development strategy discussion; Lead or coordinate both local and global team on registration plan; Be accountable on the implementation the decided project registration strategy by projects planning and tracking
•Be accountable on achieving the target timeline of submission and approval; Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings; Be accountable on the communication with Global team on the related regulatory issues on the responsible projects.
•To solve the regulatory issues via communication and negotiation with HAs if necessary;Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);Lead or chair the CPT meetings for responsible project and be accountable to provide regulatory support to other functional team;
•Contribute to optimize DRA internal operational procedures whenever is needed;Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI,PSUR, RMP, registration master file and timely update in DRAGON;
•Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs/WIs during routine work;
•Monitor regulatory changes and report to department head timely; Support line manager to control project cost according to budget
•Coach the junior levels; Acting as deputy in the absence of the department head and lead team daily operation

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
•At least 4 years in RA and/or drug/biologic development which include 2-3 years and above of demonstrated accomplishment in RA filed;
•The experience in filing global trial CTA independently;
•The experience in filing and obtaining NDA approval;
•The experience in various types of regulatory submission/approvals;
•The experience in oncology product submission is a plus.

Desirable requirements:
•Bachelor or above with Pharmaceutical/Medical background
•Fluency in English and Chinese (oral and written)

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.

Company

At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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