Regulatory Affairs Manager

Job Description

Internal Role Title: Brand Regulatory Manager

Location: Beijing, Hybrid

About the role:
In this role, you will be accountable for regulatory strategy development and the implementation of the registration strategy in China.

Key Responsibilities:
 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; Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI,PSUR, RMP, registration master file and timely update in DRAGON;
 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
 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

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Essential Requirements:
 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;

Desirable Requirements:
 Bachelor or above with Pharmaceutical/Medical background;
 Fluency in English and Chinese (oral and written).

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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, join the Novartis Network here: https://talentnetwork.novartis.com/network . You can follow us via Novartis Group Recruitment WeChat Official Account and Novartis Group WeChat Video Account.