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

We are looking for Regulatory Affairs Specialist to join our team.

The role is responsible for preparing Turkish regulatory dossiers for the registration applications of new products, covering chemical and pharmaceutical products across preclinical and clinical sections, in compliance with applicable regulations and guidelines. It also involves reviewing, preparing, submitting, and following up on regulatory processes for new products, as well as preparing initial GMP and GMP renewal applications.

The position is responsible for preparing registration and variation applications to ensure the continued registration of marketed products, monitoring and following up on general expenditures related to registration activities, and supporting the coordination of regulatory and compliance processes in line with company and country-specific requirements.

The role also supports the maintenance of the existing registered product portfolio, ensures that regulatory and compliance activities are delivered within agreed timelines, and confirms that all systems are in place to meet internal and external requirements.

Qualifications

Candidates should hold a bachelor’s degree, preferably in Pharmacy, Chemistry, Biology, Engineering, or a related field, and have a minimum of two years of experience in Regulatory Affairs or a related area within the pharmaceutical or medical devices industry. Excellent planning skills and strong attention to detail are required, along with strong multitasking skills and the ability to work effectively in a fast-paced environment.Proficiency in Microsoft Word, Excel, and PowerPoint is expected, together with advanced written and spoken English proficiency.

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

Recruitment Fraud Alert

We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

Protect yourself by verifying job offers and communications. Your safety is important to us.

Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.