Regulatory Affairs Manager

Johnson & Johnson; Fatih; Hybrid; TRY 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work model (3 days office, 2 at

Job summary

Johnson & Johnson Innovative Medicine in Istanbul is seeking a Regulatory Affairs Manager to lead regulatory strategies for a diverse portfolio within the TURGAN Cluster. Reporting to the Head of Regulatory Affairs, this role develops strategies, manages registrations and lifecycle activities, and ensures local compliance with Turkish regulations while collaborating with regional and global teams.

You will lead regulatory submissions, labeling updates, health authority interactions, and

Qualifications

• Bachelor's degree in a relevant field.
• Hybrid working model: 3 days office, 2 days home.
• 8+ years Regulatory Affairs experience in pharma.
• 2–3 years Regulatory Affairs Manager experience with cross-functional teams.
• Strong knowledge of Turkish pharmaceutical regulations.
• Experience in regulatory strategy, submissions, and lifecycle management.
• Excellent stakeholder management, communication, and leadership.
• Fluent in English and Turkish.
• Results-oriented, strategic thinker aligned with Credo values.

Responsibilities

• Develop and execute regulatory strategies for new products and lifecycle activities.
• Lead submissions, dossier review, and approval tracking.
• Manage marketing authorizations, variations, and labeling updates.
• Ensure timely implementation of approved changes in systems.
• Support activities required for new product launches.
• Engage with health authorities, industry groups, and external partners.
• Ensure compliance with regulations, policies, and ethics.
• Collaborate with cross-functional teams to achieve objectives.
• Support inspections, regulatory assessments, and documentation archiving.

Skills

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Fact-Based Decision Making

Industry Analysis

Regulatory Affairs Management

Regulatory Compliance

Strategic Thinking

Education

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

Job description

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 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.

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:

Ideal Candidate Profile

• 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:

• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility