Regulatory Affairs, Associate Specialist

Perrigo Company plc; Fatih; Hybrid; TRY 45,000 - 70,000; Full time

Job summary

A leading health and wellness company is seeking a Regulatory Affairs professional in Fatih, Turkey. The role involves managing regulatory activities for existing products and supporting new product development. Candidates must have at least two years of experience in Regulatory Affairs, excellent communication skills in Turkish and English, and a degree in a scientific field. This position offers a hybrid-working model and various benefits to support your well-being.

Benefits

Competitive compensation

Career development opportunities

Flexible remote work options

Qualifications

• Minimum of 2 years work experience in Regulatory Affairs.
• Experience in Medical Devices, Biocides, Cosmetics, or Medicines required.
• Ability to manage multiple projects simultaneously.

Responsibilities

• Manage regulatory activities for existing products.
• Support new product development regulatory tasks.
• Liaise with local regulatory authorities regarding applications.

Skills

Excellent communication in Turkish

Excellent communication in English

Proficient computer skills

Detail-oriented

Flexible and adaptable

Education

University Degree in a Scientific Subject

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Veeva

TVT

Trackwise

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality & Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.

Scope of the Role

• Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;
• Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;
• Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;
• Maintain regulatory files and data systems in compliance with SOPs;
• Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;
• Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;
• Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;
• Support in the communication with local regulatory authorities regarding license applications and notice of change.

Experience Required

• University Degree in a Scientific Subject;
• Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;
• Excellent communicator in Turkish and English;
• Proficient computer skills esp. Microsoft (Word, Excel, PowerPoint); experience with Veeva, TVT, Trackwise is an asset;
• Eye for detail, punctual, well organized;
• Being flexible and adaptable to change;
• Ability to support several concurrent projects/products simultaneously;

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

Hybrid Working Approach

We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo