Regulatory Affairs Associate

Job description

Job Overview

This role will provide a global range of regulatory affairs responsibilities, which support our business in achieving its business goals.

This role will report to the Regulatory Manager and will be responsible for managing products under development and/or marketed products.

Key Responsibilities

·  According to the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products,
·  Interface with various project/product teams,
·  Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation,
·  Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements,
·  Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate together with Regulatory Manager,
·  Manage the maintenance of a portfolio of products,
·  Accountable for keeping the databases updated on a timely basis for portfolio they are in charge of,
·  Provide support and communicating information on products to other functions,
·  Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies,
·  In liaison with their manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, recall etc.,
·  Support the consolidation and provision of regulatory expertise and giving input about requirements and needs,
·  Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

Requirements & Qualifications

·  Minimum Bachelor’s Degree in Medicine, Pharmacy, Chemistry Sciences.
·  Minimum 3 years experience in a similar position in different types of registrations, preferably in multinational organization
·  Project management experience in the pharmaceutical industry or in a regulatory environment.
·  Ability negotiation & communication skills
·  Good at organization skills and high accuracy in documentation
·  Having high sense of urgency
·  Good knowledge of new decrees & guidelines
·  Multitasker, awareness and adherence to company internal SOPs & compliance standards
·  Promptness in respond to authorities requirements and prompt in deliverables
·  Analytical, problem solving, presentation skills
·  Fluent in English and Turkish both written and spoken

Location information

·  Istanbul

Terms of Employment

·  This full-time position does not have people management responsibility.
·  There might be some travel required for this position.

What Sanofi Can Offer You

·  Development opportunities to own your future to enhance your life journey
·  An open and inclusive environment where you can be yourself
·  Social activities and wellbeing programs to support your life

We do not stop there, Explore:

·  Hybrid Working Options (for Istanbul HQ and for eligible white collar positions at M&S site)
·  Comprehensive Medical Plan
·  Company Private Pension Plan
·  Flexible Benefits Program for YOU to design your benefits
·  Company car for eligible positions & attractive lunch voucher/cafeteria at M&S site
·  Birthday Leave to celebrate YOU
·  14-week Parental Leave
·  Employee Stock Purchase Plan dedicated to Sanofians
·  Kindergarten Allowance for female employees
·  Employee Assistance Program
·  Access to various learning & development resources, career development opportunities

& MORE!

We chase the miracles of science to improve people’s lives.

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.  

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.

We are one of the largest pharmaceutical companies in Turkey, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkey, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.

Our factory in Lüleburgaz is one of the leading pharmaceutical manufacturing plants in Turkey. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site, produces high-quality pharmaceuticals in many different forms in accordance with global health standards, and develops generic medicine at its on-site R&D Center.

Pursue progress.

Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles.

So let’s be those people.

Let’s explore more, and share a purpose, as well as our skills. Let’s reinvent healthcare, chase change, and embrace new ideas. Let’s take bigger risks and find better solutions for the people we help.

Let’s pursue progress.

And let’s discover extraordinary, together.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.