Regulatory Affairs Sr Specialist
Regulatory Affairs Sr Specialist
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Job Description
Primary Job Function/Mission
Support the of regulatory strategies for all products assuring the inclusion of the latest regulatory framework to get final approval of Marketing authorization at the best timeline possible and according with AbbVie policies.
Ensure no significant business interruptions due to regulatory compliances issues. No market actions that impact patient safety. No critical observations from authority inspections /audits.
Core Job Responsibilities
Ensure correct management New Marketing Authorization and key strategic submissions across the portfolio in charge.
Maintain product license in compliance with market supply and local authority regulations.
Ensure alignment with all applicable SOPs
Manage agency interface for safety and compliance issues.
Support local due diligence and Lex process within the required timelines to ensure compliance of planned launch dates.
Interactions with local regulatory authority as required facilitating the review responses to questions and approval of all local submissions in a timely manner.
Completion of any post approval commitments.
Provide Regulatory support for the timely submission of new drug applications.
Review and approval of promotional materials.
Lead all labeling harmonization / compliance processes assuring KPIs results
Ensure the maintenance of databases
Provide regulatory support for cross functional programs and activities e.g. pricing reimbursement Activity government bids.
Ensure prescribing information labels and other packaging components are aligned with regulations and core safety information
Participation in Regulatory Intelligence anticipating new regulation and competitors activities.
Qualifications :
Education
- Bachelors in Pharmacy Chemical Engineering and correlated areas
- Advanced English skills (Written and Spoken)
- At least 45 years of experience working within the pharma industry in Quality and Regulatory activities. Consumer health care regulatory processes management is a plus.
- Good communication and negotiation skills.
- Leadership Management skills.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
