Regulatory Affairs Coordinator
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
Purpose
Coordinate all the required activities with Area Therapeutic Area Teams and local stakeholders to ensure that the dossier content complies with local regulations to submit to the local Health Authority the required applications in order to obtain the marketing authorization for new products or the required variations or renewal.
Coordinate all the required activities for label update based on reference label to submit to the local Health Authority according to KPIs timelines.
Execute the review and approval process of advertising, promotional and non-promotional materials in compliance with the applicable regulations and company policies.
Coordinate all the required activities with Area Therapeutic Area Teams to ensure the availability GMPc issued by the local Health Authority for the applicable products/manufacturing sites.
Control and guard of GMPs, CPPs, PoAs, LoAs, and other legal documents
ADVERTISING Prepare the advertising application files for Cofepris submission and coordinate the submission dates with MKT.
Update global regulatory systems in compliance with the timelines defined.
Responsibilities
Review and validate the translation to Spanish of documents translated by Area and local translations.
Coordinate the translation to Spanish of the technical, legal and/or clinical support documentation provided by global.
Prepare, review and integrate the files for the submission to the local Health Authority.
Ensure the dossier meets with the local requirements according to the corresponding regulations
Execution of the activities required for the Subcommittee of Evaluation of Biotechnology Products & New Molecules Committee presentation.
Give a close follow up to internal activities needed for the review & approval of administrative & technical variations.
Develop the local labeling texts ensuring that they meet with local regulations, internal SOP and the reference document provided by AREA.
Drive labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer.
Ensure that the GMPs and other legal regulatory documents of manufacturing sites are valid during the entire lifecycle of the marketing authorization. Applicable for documents issued by the local Health Authority or other regulatory agencies.
Maintain the archive of the GMPs, CPPs, PoAs, LoAs, and other legal documents and maintain the control of the documents ensuring that the originals are kept and ensure there is always available at least one certified copy of each document [SCAL1] and request new certified copies to the Administrative Assistant.
Keep updated the tracking database and due dates for the request of the GMPs, CPPs, PoAs, LoAs, and other legal documents to the GSSC. [SCAL2]
Review of advertising and promotional material in Veeva and submission to Cofepris.
Prepare, submit and obtain the approval for local biological product release.
Participate in the assigned meetings internally and externally.
Execute all the activities described in alignment with AbbVie culture and philosophy.
Keep updated the applicable SOP.
Keep updated the global regulatory systems.
Position Accountability / Scope
Maintain budget control.
Internal areas of interaction: Sanitary responsible, Quality Assurance, Marketing, Medical, Pharmacovigilance, Demand, Market Access, AREA Regulatory, this list is enunciative and not limitative, any other interaction area required may be included in the scope.
External Areas:
Mexican National Regulatory Agency (COFEPRIS), industry associations (CANIFARMA, AMIIF) and A&AS Area (Area and Affiliate Support)
Qualifications
Qualifications
Education Requirements: Bachelor degree. Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related demonstrable professional degree.
2 to 5 years in a similar position.
Knowledge in Health regulation in Mexico.
Good communication skills.
Good relationships with internal stakeholders.
Continuous tracking of self and other activities.
Fluent in English written and spoken.
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 305 comparable Regulatory Affairs roles across 67 biopharma companies.
Salary context
85 of 305 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 305 comparable roles
+ 31 more countries
Seniority mix
261 of 305 peers have a known seniority level
Therapeutic area mix
33 of 305 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.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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.