Sr. Specialist/AM, Regulatory Affairs (Beijing, China)
About this opportunity
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Responsibilities
1. Work independently on projects, communicate with HQ of company to request registration documents and samples.
2. Prepare and submit the registration dossier for new products, IDL renewal and variation application.
3. Follow up and push QC test, CDE review & NMPA approval process to obtain the approval timely.
4. Registration dossier management
5. Implement DRA sop.
6. Other harmonization work in DRA.
Qualifications
-Bachelors degree or above (e.g. MBA, MSc) in Pharmaceutics, Chemistry, Biology or other relevant major
-Good project management skill and experience. Be able to work with a keen sense of urgency and priority. Strong learning ability;
-Good relationship & experience with relevant authorities is preferable
-Good personalities with team spirit;
-Good interpersonal and communication skills.
-At least 5 years import drug registration working experience
-Language skills & proficiency: Good written and oral communication skills in Chinese & English language
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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 88 comparable Senior Regulatory Affairs roles across 40 biopharma companies.
Salary context
38 of 88 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 88 comparable roles
+ 12 more countries
Seniority mix
88 of 88 peers have a known seniority level
Therapeutic area mix
6 of 88 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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How we calculate "similar"
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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.