Regulatory Affairs Manager

7347-Johnson and Johnson Sihhi Malzeme Sanayi Ve Ticaret Limited Sirketi Legal Entity

Fatih

Hybrid

TRY 900,000 - 1,300,000

Full time

4 days ago

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Job summary

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Manager to be based in Istanbul / Türkiye. The role leads regulatory activities for a diverse portfolio, shaping strategies and coordinating submissions with local and cross-functional teams.

The position requires 8+ years in Regulatory Affairs, strong knowledge of Turkish regulations, and fluency in English and Turkish, with a hybrid work model (3 days in office, 2 days at home).

Qualifications

Bachelor's degree in a relevant field.
Hybrid working model (3 days office, 2 days home).
Minimum 8 years of Regulatory Affairs experience.
Minimum 2-3 years of Regulatory Affairs Manager experience.
Strong knowledge of Turkish pharmaceutical regulations.
Fluent English & Turkish.

Responsibilities

Lead regulatory strategies for new products and lifecycle management.
Oversee submissions, variations, renewals, and labeling updates.
Engage health authorities and industry partners to advance programs.
Ensure compliance with regulations and quality systems.
Collaborate with cross-functional teams to meet business goals.

Skills

Regulatory strategy

Cross-functional leadership

Stakeholder management

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or related discipline

Job description

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

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Manager to 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 approval tracking of regulatory dossiers. Manage marketing authorization applications, variations, renewals, and labeling updates. Ensure timely implementation of approved changes within company systems and processes. Support activities required for new product launch
Stakeholder Engagement Build and maintain strong relationships with health authorities, industry associations, internal & external partners, and key stakeholders. Represent the company in external regulatory forums and industry working groups when appropriate.
Compliance & Quality Ensure compliance with all applicable regulations, company policies, and ethical standards. Support inspections, audits, and regulatory assessments. Maintain accurate regulatory documentation and archival systems.
Cross-Functional Leadership Partner with Medical Affairs, Supply Chain, Quality, Legal, Market Access, Government Affairs, Commercial, and Global Regulatory teams to deliver business objectives. Contribute as a key Regulatory representative within Cross-Functional Value Teams (CVTs). Support knowledge sharing, continuous improvement, and operational excellence initiatives.

Qualifications & Requirements

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or related discipline.
Available to work with the Hybrid working model (3 days office, 2 days home)
Minimum 8 years of Regulatory Affairs experience within the pharmaceutical industry.
Minimum 2-3 years of Regulatory Affairs Manager experience, demonstrated success in working cross-functional teams and complex regulatory projects.
Strong knowledge of Turkish pharmaceutical regulations and regulatory procedures.
Demonstrated experience in regulatory strategy, submissions, and lifecycle management.
Effective stakeholder management skills.
Strong communication, influencing, and leadership capabilities.
Fluent English & Turkish
Results-oriented, strategic thinker with strong planning and organizational skills.
Following and matching with our Credo values.

Preferred Skills