Regulatory Affairs Manager

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Istanbul, Turkey

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Managerto be based in Istanbul / Türkiye.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Position Summary:

To lead regulatory activities across a diverse pharmaceutical portfolio within the TURGAN Cluster.

Reporting directly to the Head of Regulatory Affairs, TURGAN Cluster, this role is responsible for developing and executing regulatory strategies, managing product registrations and lifecycle activities, ensuring compliance with local regulations, and serving as a key partner within cross-functional value teams.

A responsible person will lead regulatory submissions, labeling updates, health authority interactions, and regulatory intelligence activities while contributing to portfolio growth, business objectives, and patient access.

The role requires strong collaboration with local, regional, and global stakeholders, proactive management of regulatory risks and opportunities, and effective representation of the company with health authorities and industry associations.

Key Responsibilities

Regulatory Strategy & Portfolio Management


* Develop and execute regulatory strategies for new products, new indications, renewals, and other lifecycle management activities.


* Provide strategic regulatory input to support portfolio and business objectives.


* Assess regulatory risks, opportunities, and health authority expectations.


* Monitor and communicate regulatory developments that may impact the business.

Submissions & Lifecycle Management


* Lead preparation, review, submission, and app...