Regulatory Affairs Manager

Biopharma Careers; Fatih; Hybrid; TRY 400,000 - 700,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Johnson & Johnson Innovative Medicine, based in Istanbul, Türkiye, is seeking a Regulatory Affairs Manager to lead regulatory activities across a diverse pharmaceutical portfolio within the TURGAN Cluster. Reporting to the Head of Regulatory Affairs, this role will shape regulatory strategies, manage registrations and lifecycle activities, and coordinate with local, regional, and global stakeholders.

The ideal candidate will have broad regulatory experience, strong leadership, and fluency in

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or related discipline is required.

Responsibilities

• Develop regulatory strategies for new products, indications, renewals and lifecycle management.
• Lead preparation, review, submission and 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 launches.
• Build and maintain relationships with health authorities, industry associations and internal/external partners.
• Represent the company in regulatory forums and industry groups.
• Maintain regulatory documentation and archival systems.
• Collaborate with cross-functional teams to deliver business objectives.

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

Education

Bachelor's degree in Pharmacy or related field

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 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

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

Required 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

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