R&D - GRA - Regulatory Affairs Manager - BJ
About this opportunity
Job Title: Regulatory Affairs Manager, I&I Alliance
Reports to: TA Head, I&I Alliance, China
Team Management: Individual Contributor
Key Responsibilities:
China – I&I Alliance
Support the development and implementation of appropriate regulatory strategies for I&I Alliance products in China, under the guidance of the TA Head.
Lead cross-functional teams to ensure timely submission and delivery of Marketing Authorisations in China in line with agreed strategy, and manage the consequent lifecycle management activities.
Manage regulatory processes effectively and in compliance with internal standards and regulatory requirements, ensuring appropriate dossier quality for submissions and overall regulatory compliance in China.
Establish effective coordination of regulatory activities in China, supporting cooperation with the China Business Unit and Global divisions.
Work across project teams to evaluate regulatory pathways, risks, and timelines for assigned I&I Alliance products.
Build effective collaboration with the GRA (Global Regulatory Affairs) team to maximize synergies in regulatory activities.
Monitor and adopt new regulatory requirements and Group standards to ensure ongoing regulatory compliance in China.
Communicate regulatory environment changes to relevant stakeholders and proactively anticipate future trends.
Lead cross-functional collaboration to provide necessary regulatory support for I&I Alliance products.
Proactively share new product development status and get alignment with GRL in a timely manner.
Qualifications & Requirements
Education Bachelor's degree required in Pharmacy, Medicine, Life Sciences or related field; Master's degree or above preferred
Experience Minimum 8 years of regulatory affairs experience in the pharmaceutical industry, with solid experience in China regulatory submissions
Language Proficient in both Chinese and English with fluent communication skills (written and spoken)
Skills Strong project management and cross-functional coordination skills; ability to lead submission teams without direct authority; good understanding of NMPA requirements and global regulatory frameworks
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 145 comparable Manager Regulatory Affairs roles across 41 biopharma companies.
Salary context
37 of 145 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 145 comparable roles
+ 17 more countries
Seniority mix
145 of 145 peers have a known seniority level
Therapeutic area mix
22 of 145 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.