Job Description
Job Title: Regulatory Specialist Contractor
Duration: 12 months
Responsibilities:
In this role, you will be part of Turkiye Regulatory team to work closely with Regulatory Manager.
Main responsibilities of the role can be summarized as follows:
Develop & plan regulatory strategy for the assigned products in cooperation with Global and local business partners.
Prepare applications to MoH (Ministry of Health) and follow up the process with ensuring continuous communication with MoH and associations.
Prepare Type I & II variations and renewal dossiers.
Prepare and update SmPC & PILs.
Control of AWs of packaging materials and give approval in relevant systems.
Filing and storage of all registration relevant documents in the appropriate folders as determined in relevant SOPs.
Updating the electronic global and local databases periodically.
Respond to spontaneous requests from authorities promptly and accurately ensuring that all relevant in-house liaison has taken place to avoid misinformation or communication breakdown.
Give support for internal audit readiness.
Qualifications:
Scientific degree from Pharmacy, Biology, Chemistry or Chemical Engineering departments.
Have a good command of written and spoken English.
Be computer literate (Word, Excel, PowerPoint, MS Project, Acrobat, Internet, Intranet, etc.).
Have good presentation skills.
Be familiar with legislation governing the activities of the pharmaceutical industry.
Have good communication-influencing skills.
#LI-PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
School of Leaders
We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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