Regulatory Affairs Manager
About this opportunity
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
PRIMARY FUNCTION/OBJECTIVE
The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing approvals of company products, to provide advice on regulatory matters to staff and customers and design RA strategy and lead cross functional meeting.
RESPONSIBILITIES
Independently manage registration of new products and variations to marketed products (including medical devices) to ensure regulatory approvals are achieved in accordance with company objectives.
Ensure new product registrations including BSE submissions and approval maintenance is conducted in a timely manner according to the registration plan.
Coordinate responses to deficiency letters and other requests for data from regulatory authorities for products and ensure it meets agreed or required timelines.
Liaise with officials of government agencies to facilitate evaluation processes and respond to requests for data in agreed timelines.
Update product labeling in a timely manner based on the update of the product labeling from headquarters
Review labeling and product information to ensure compliance with relevant regulations and codes.
Generate registration plans and provide regular status reports.
Report progress and status to manager and management as required including to corporate RA and NPI meetings.
Design RA strategy and lead cross functional meetings.
Independently manage development projects, including early pipeline products, from RA perspective.
Communicate regulatory issues and evaluate the impact on the business to RA director, senior management, Business Unit and GM where applicable.
Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance.
Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes in a timely manner to related parties and management.
Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe.
Participate in RA process and streamline processes to increase productivity.
Lead the team in the management of the regulatory projects
Manage the performance of team members
Other regulatory projects and tasks assigned by RA Director.
Qualifications
University degree in Pharmacy, Pharmacology, Biology or related disciplines
About 8 years’ experience and in-depth knowledge of Taiwan Regulatory in Medical Device or Pharmaceutical Industry. New drug applications for NCE and clinical drug development knowledge will be an added advantage.
Strong communications and coordination skills
Proficiency in communicating strategic and tactical issues to management
Proven interpersonal skills
Excellent oral, written and good computer communication skills, including fluent English.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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 179 comparable Manager Regulatory Affairs roles across 65 biopharma companies.
Salary context
58 of 179 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 179 comparable roles
+ 20 more countries
Seniority mix
179 of 179 peers have a known seniority level
Therapeutic area mix
17 of 179 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"
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.