Regulatory Affairs Regional Project Manager

3 semanas atrás

Lisboa, Portugal Organon Tempo inteiro

**Job Description**:
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.

**Purpose of the role**

In the role of Regulatory Affairs Regional Project Manager you will manage a global regulatory change projects with high complexity. You will work with the 30-40 countries to facilitate on-time regulatory approvals and making sure the changes do not impact supply to our patients. You will be the liaison between the global sourcing management team and the in country regulatory leads. You will closely work with your regional counter parts across the globe within regulatory and CMC to improve the processes. You are a driver of change and you are expected to work solution oriented.

**Main responsibilities**
- Plan and track on-time initial submissions and RtQs (assumption to have filling plan complete);
- Confirm SKU list including deletions (timing);
- Define the complete submission packages, chase various package components;
- Continuous monthly check-ins with concerned countries;
- Request, chase and track ancillary documents (procurement);
- Standardize and harmonize documents to gain efficiency where possible;
- Identify local colliding projects and variation;
- Communicate master data updates;
- Escalate shifts from the plan and bundling opportunities;
- Identify and escalate any identified risk;
- Communicate and action risk mitigation (e.g. stock plans, re-distribution);
- Track Health Authority (HA) submission and authorizations;
- Track artwork changes and implementation to new SKU's.

**Your profile**
- Master’s degree in health (sciences), life sciences, medical sciences or another relevant field of study;
- A minimum of 10 years of industry/work experience in regulatory affairs;
- Experience with diverse markets and with the roll out of technical change projects and understand the complexity of the regulatory process up until the implementation to supply;
- You are structured, process oriented, organized and analytical;
- You have good communication skills, you are quality oriented and you do have a great eye for details;
- You are flexible, can adapt to changing priorities and you know how to operate independently as well as in a team;
- You possess good communication and time management skills and you know how to work solution oriented;
- You are ‘patient focused’ and you will always put safety first;
- You are fluent in English (written and spoken).

**We offer**

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our compensation and benefits package is very competitive.

**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.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Employee Status**:
Project Temps (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**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
2
**Requisition ID**:R519860

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