Regulatory Affairs Analyst

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Job Description

Job Purpose

The role has responsibility for all of Takeda Türkiye activities in Regulatory Affairs including interactions with regulatory authorities, government bodies and lobbying interactions with the regulatory area. She/he is accountable for ensuring Regulatory excellence by aiming for the optimal registration approval timelines and lifecycle of Takeda medicines. Responsible for directing all day to day regulatory affairs activities in the country  to ensure compliance with all local regulations. Implements regulatory strategies for the earliest possible product approvals for launch & growth products  and ensures the timely creation, preparation, and achievement of organized valid regulatory submissions. The role reports to Head of Regulatory Affairs. As a requirement of business compliance, ensures the confidentiality of company’s business critical information, plans, ideas and strategies.Responsibilities for this position require flexible working hours and occasional travel to align with stakeholders’ and organizational schedules, locations and meeting timelines.

Role Core Responsibilities & Accountabilities

Regulatory Strategy & Planning

• Monitor regulatory updates and stay up-to-date related to regulatory changes.
• Support tracking of key regulatory issues and competitor activities impacting the pharmaceutical industry.
• Identify potential regulatory risks and support the update of registration plans when required.

Registration Processes & Lifecycle Management

• Prepare and submit GMP inspection dossiers and regulatory submissions (NDAs, line extensions, variations, license in/out applications) in compliance with local laws and planned timelines.
• Support labelling activities and coordinate with Medical and Pharmacovigilance Units for clinical and safety-related updates.
• Contribute to maintaining continuity of existing licenses and obtaining new approvals as needed.
• Ensure corporate regulatory databases are regularly updated and documentation is maintained accurately and securely.

Internal Stakeholder Collaboration

• Collaborate with cross-functional teams to clarify regulatory requirements and provide timely support.
• Participate in launch planning by sharing submission and approval timelines and contributing to related discussions.

Compliance & Reporting

• Forward quality complaints to the Quality Team and adverse event reports to the Pharmacovigilance Team within 24 hours.
• Ensure proper documentation, trustworthy record-keeping, and regular updates to corporate regulatory databases & reports including but not limited to all GRA compliance reports.
• Support in the preparation and updating of the regulatory budget.

External Engagement

• Support interactions with regulatory authorities under the guidance of the manager.
• Participate in industry association meetings when required.

Role Mandatory Responsibilities

• Adhere to Takeda’s Information Security and Technology Use policies.
• Serve as a Quality Ambassador by promptly reporting any product-related concerns to the Quality team.
• Uphold integrity and ethical conduct in alignment with Takeda’s values (Takeda-ism).
• Complete all mandatory trainings and ensure team compliance with relevant policies and procedures.
• Lead by example in the accurate and timely use of company systems (e.g., Concur, Dakika, Bloom), fostering process discipline across the team.
• Proactively raise compliance or ethical concerns through appropriate Takeda reporting channels.

Job Dimension

• OPEX responsibility: No
• Financial Responsibility: No
• Volume Impact: No
• Revenue Impact: No

Role required Qualifications & Capabilities

Qualifications

• Education: BSc Degree in Pharmacy, Chemistry, Chemical Engineering or Life Sciences. MSc degree in life sciences is preferred.
• Language: Excellent command of written and spoken English
• Experience: Experienced minimum 5 year of working experience in Regulatory Affairs
• Digital Dexterity: Actively uses digital tools, e-CTD systems, and regulatory platforms to improve efficiency and accuracy.

Capabilities

• PTRB Alignment: Applies PTRB principles consistently in regulatory activities and decision-making.
• Teamwork & Independence: Works independently on assigned tasks and collaborates effectively with cross-functional colleagues.
• Problem-Solving & Analysis: Applies strong analytical skills to resolve moderately complex regulatory issues.
• Planning & Execution: Demonstrates advanced planning and effective prioritization, delivering results with minimal supervision.
• High-Quality Delivery: Consistently delivers accurate, compliant, and high-quality outcomes.
• Strategic & Flexible Thinking: Supports strategic discussions with flexible thinking, proactively considering different perspectives.
• Resilience & Proactivity: Remains calm under pressure, takes initiative, and ensures timely completion of deliverables.
• Positive & Collaborative Approach: Maintains a constructive outlook and fosters collaboration across teams.
• Stakeholder Management: Builds and maintains effective relationships with internal stakeholders; supports interactions with external parties.
• Business Acumen: Understands market and business dynamics, contributing insights to regulatory planning.
• Forward-looking & Innovative: Identifies opportunities for improvement and suggests innovative approaches within scope of responsibility.
• Efficiency & Collaboration: Delivers regulatory outcomes efficiently while promoting cross-functional collaboration.
• Adaptability: Demonstrates agility in responding to changing regulatory requirements and shifting priorities.
• External Engagement: Supports representation of Takeda in front of authorities and industry associations under guidance.

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