Regulatory Affairs Specialist

AbbVie; Fatih; On-site; TRY 250,000 - 350,000; Full time

Job summary

AbbVie in Turkey is seeking a Regulatory Affairs Specialist to prepare Turkish regulatory dossiers for the registration of new products, including chemical and pharmaceutical products, across preclinical and clinical sections in accordance with applicable regulations.

The role involves reviewing, preparing, submitting, and tracking regulatory processes for new products, as well as preparing GMP and GMP renewal applications and maintaining the portfolio to meet internal and external requirements.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field.
• Minimum of two years of experience in Regulatory Affairs or related area in pharma/medical devices.
• Advanced written and spoken English required.

Responsibilities

• Prepare Turkish regulatory dossiers for registration applications of new products.
• Review, prepare, submit, and follow up on regulatory processes for new products.
• Prepare initial GMP and GMP renewal applications.
• Maintain the registered product portfolio and ensure regulatory activities meet timelines.

Skills

Regulatory affairs

Attention to detail

English proficiency

Multi-tasking

Education

Bachelor’s degree

Tools

MS Office

Regulatory databases

Job 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.

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