Senior Regulatory Affairs Analyst
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
- Autonomously execute regulatory activities of minor moderate and major complexity including new product registrations and moderate/major postregistration changes and medical device products.
- Propose pragmatic regulatory solutions for complex situations assess crossfunctional impacts and align recommendations with company strategy.
- Follow and help operationalize the regulatory strategy established with the Regulatory Affairs Leadership.
- Actively participate in local business and regulatory strategy meetings and represent the company in meetings with class entities when required.
- Serve as a local expert/focal point on complex regulatory issues monitoring legislation assessing regulatory impact and developing implementation plans for new legislation or requirements.
- Prepare define and revise all registration and postregistration documentation in accordance with Brazilian law and company procedures.
- Prepare legal text and review final package insert (leaflet) wording and labeling/artwork for legal consistency with registration and legislation.
- Request and monitor inspections of AbbVie sites and partners abroad and follow GMP inspection processes until closure.
- Ensure accurate updates to AbbVie regulatory systems and spreadsheets (registrations package inserts labeling legal documents cGMP documentation) and maintain control of the registration/package update workflow in regulatory systems.
- Review and approve promotional materials in accordance with internal policies codes of conduct and applicable legislation.
- Provide regulatory guidance to internal client areas and stakeholders and mentor junior regulatory analysts to accelerate issue resolution.
- Comply with company Codes of Business Conduct and Ethics and all relevant policies and procedures.
Qualifications :
- Bachelors degree in Pharmacy Biomedicine Chemistry Biology or related lifescience field.
- Experience in Regulatory Affairs within the pharmaceutical or biotechnology industry with handson experience in ANVISA submissions and postapproval change management (medicines and medical devices).
- Demonstrated experience with labeling/package insert text regulatory dossier preparation and interactions with regulatory authorities.
- Knowledge of GMP inspection processes with manufacturing partners.
- Strong organizational skills attention to detail and ability to manage multiple priorities autonomously.
- Excellent verbal and written communication skills.
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
