Regulatory Affairs Specialist - Turkey

Organon Türkiye; Fatih; On-site; TRY 240,000 - 360,000; Full time

Job summary

Organon Türkiye in Istanbul seeks a Regulatory Affairs professional to execute regulatory activities for products to reach market in line with company plans. You will handle timely submission and follow-up of labeling, CMC variations and GMP submissions, ensuring compliance with local regulations and Organon policies.

The role demands leadership in shaping regulatory strategy, staying current with evolving regulations, and coordinating with HQs and local partners.

Qualifications

• Bachelor's Degree in Pharmacy (preferred), Chemistry, Chemical Engineering.
• Minimum 2 years of experience in Regulatory Affairs in similar position.
• Must have experience in Pharma Industry.
• English Fluency.
• Leadership competencies.
• Strategic thinking and proactive management capability.
• Collaboration and active communication.
• High sense of customer orientation.
• High sense of collaboration.
• Advanced negotiation skills.
• Must be based in Istanbul.

Responsibilities

• Maintenance of existing products (%60)
• Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations and GMP related submissions, in cooperation with the key stakeholders.
• Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.
• Ensures timely and proper submissions for license transfers of related products Handles the control of packaging components artworks developed by labeling coordinator.
• Works in close collaboration with Labeling Coordinator for the artworks’ approval process and the follow-up of the printing process to ensure proper implementation of artworks changes.
• Coordination and close follow-up with local partners.
• Regulatory Compliance (%25)
• Updates and implements local regulatory procedures in a timely manner, in close synergy with the Regional organization.
• Adapts new regulatory procedures to his/her job.
• Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
• Coordination and close follow-up with local partners
• Updates local and global systems frequently.
• Shape regulatory environment (%15)
• Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.
• Interacts with Ministry of Health when needed.
• Keeps abreast of trends and legislation, at both national and international levels.
• Provides advice and recommendations to Management and to Regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.

Skills

Leadership

Strategic thinking

Collaboration and active communication

Customer orientation

Advanced negotiation skills

English Fluency

Education

Bachelor's Degree in Pharmacy (preferred), Chemistry, Chemical Engineering

Job description

• Under the direction of the Regulatory Lead/Senior Regulatory Specialist, the incumbent:
• Executes regulatory activities for products in order to get products to market according to company plans.
• Handles timely submission and follow-up of labeling & CMC variations and GMP submissions.
• Ensures permanent compliance to local regulatory requirements and to Organon’s policies and procedures.
• Demonstrates clear leadership in shaping the regulatory environment to support company objectives.
• Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
• Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.
• This position is a one-year contract, it may be extended depending on the business need.

Job Description

The Position

• Under the direction of the Regulatory Lead/Senior Regulatory Specialist, the incumbent:
• Executes regulatory activities for products in order to get products to market according to company plans.
• Handles timely submission and follow-up of labeling & CMC variations and GMP submissions.
• Ensures permanent compliance to local regulatory requirements and to Organon’s policies and procedures.
• Demonstrates clear leadership in shaping the regulatory environment to support company objectives.
• Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
• Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.
• This position is a one-year contract, it may be extended depending on the business need.

Responsibilities

• Maintenance of existing products (%60)
• Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations and GMP related submissions, in cooperation with the key stakeholders.
• Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.
• Ensures timely and proper submissions for license transfers of related products Handles the control of packaging components artworks developed by labeling coordinator.
• Works in close collaboration with Labeling Coordinator for the artworks’ approval process and the follow-up of the printing process to ensure proper implementation of artworks changes.
• Coordination and close follow-up with local partners.
• Regulatory Compliance (%25)
• Updates and implements local regulatory procedures in a timely manner, in close synergy with the Regional organization.
• Adapts new regulatory procedures to his/her job.
• Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
• Coordination and close follow-up with local partners
• Updates local and global systems frequently.
• Shape regulatory environment (%15)
• Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.
• Interacts with Ministry of Health when needed.
• Keeps abreast of trends and legislation, at both national and international levels.
• Provides advice and recommendations to Management and to Regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.

Required Education, Experience And Skills

• Bachelors Degree in Pharmacy (preferred), Chemistry, Chemical Engineering
• Minimum 2 years of experience in Regulatory Affairs in similar position
• Must have experience in Pharma Industry
• English Fluency
• Leadership competencies
• Strategic thinking and proactive management capability
• Collaboration and active communication
• High sense of customer orientation
• High sense of collaboration
• Advanced negotiation skills
• Must be based in Istanbul

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Temporary (Fixed Term)

Relocation:

No relocation

VISA Sponsorship

Travel Requirements:

Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Shift

Flexible Work Arrangements:

Valid Driving License

Hazardous Material(s):

Number Of Openings

1

Requisition ID:

R541345