Senior Regulatory & Quality Expert
About this opportunity
The candidate will be a key regulatory & Quality expert for the portfolio of Life Science, Pharma & Biotech industry. The candidate should have an understanding of regulatory & quality for sterile drugs/biopharmaceuticals, including IND/NDA process, GMP and relevant regulations. In addition, the candidate must be well-versed in regulatory trends relevant to Life Science products.
Your Role:
Take active role to build regulatory intelligence for Life Science. Focused area includes upstream, downstream process, raw materials management and new technologies.
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests.
Safeguard LS strategic interests and objectives in arising guidance, standards and regulation.
Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business. Analyze available regulatory and compliance information.
Increases the influence of important regulatory bodies and industry associations.
Secure flow of information from/to authorities, industry associations.
Builds and keeps personal relationships to local and national authorities.
Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.
Training for and support of internal stakeholders, external customers and relevant regulatory bodies.
Builds processes for the flow of information and regulatory intelligence within China.
Definition of processes to implement upcoming regulatory needs and requirements.
Provide regulatory & quality expertise and consultation for customer regulatory & quality inquiries, support complaints investigations. Develop the strategy and provide guidance to customers on inspection/audit readiness and drug registration, include process validation, change control, etc.
Closely work with global regulatory surveillance & advocacy team and Life Science regulatory subject matter experts to link the local advocacy activities with global advocacy activities.
Monitor competitor approach regarding regulatory requirements.
Who you are:
Education and Languages:
Master/Ph.D. Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals.
Fluent in Chinese & English (verbal and written) is required.
Professional Skills and Experiences:
Minimum of 10 years of relevant industry experience in quality & regulatory, CMC, process development and process validation related to biopharmaceutical products.
Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, Upstream and downstream process.
Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.
Experience working in a global, matrix environment.
Personal Skills and Competencies:
Strong organizational and time management skills.
Good project management skills.
Ability to train and educate others.
Effective management by influence.
Ability to work in multi-cultural teams.
Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
Ability to indirectly influence other organizations and cultures.
Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
Able and willing to travel.
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 57 comparable Senior Regulatory Affairs roles across 30 biopharma companies.
Salary context
15 of 57 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 57 comparable roles
+ 15 more countries
Seniority mix
57 of 57 peers have a known seniority level
Therapeutic area mix
5 of 57 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.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
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.