Regulatory Affairs Manager

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:

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