Regulatory Affairs Specialist
hace 4 días
**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.
It’s going to be an exciting future—come be a part of it
Responsible for all Regulatory Affairs submission requirements for their assigned product portfolio according to Organon policies and procedures in Colombia, as applicable. The Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
**Major Activities and Responsibilities**:
- Responsible for execution of local Regulatory Affairs processes and activities in alignment with Regulatory Affairs systems and their associated Quality Management System, following department Standard Operating Procedure, company Policies and Procedures and country legislation.
- Acts in full compliance with global and local Standard Operating Procedure and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions locally for non-compliance issues.
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality Regulatory Affairs data and evaluates processes for potential improvement in efficiency and effectiveness.
- Demonstrate knowledge of, and ensure compliance to, all relevant regulatory legislation and internal procedures.
- Proactively identify procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Set quality standards, by participating in the development of appropriate SOPs and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, and QA actions etc., per requirements of the internal policies and applicable local regulations.
- Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.
- Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information.
- Work on continuing improvements and simplification.
- Development and maintenance of a consolidation work plan and tracking system.
**Regulatory**:
- Responsible for all daily RA processes and activities within the countries covered by the country operation as required.
- Establish and maintain a strategic partnership through effective, timely, communication with Area Commercial, Medical and Regulatory for all products.
- Maintain product license in compliance with market supply, and local authority expectations. Ensure alignment with all applicable change control documents.
- Coordinate and assure a timely review and approval of the Artworks for packaging materials for all products.
- Support to Sales Department with Regulatory Documents (GMP certificates, Bioequivalence letters and others) for Tender Bids.
- Support the others regulatory process as required by the Manager.
Background Requirements
Degree: Pharmacist or related sciences
Postgraduate - Optional
Experience
- 3 to 5 years in Regulatory Affairs at Pharmaceutical Industry.
- Good knowledge of ICH, GMP and local regulations.
Required Knowledge
- Colombian pharmaceutical legal regulations.
- Medical Devices and In-vitro Diagnostic Reagent regulations desirable
- Regulatory activities
- Leadership behaviors
- Pharmacovigilance (desirable)
**Skills**:
- Proficient in MS Office software
- Attention to detail
- Ability to work cross-functionally in pharmaceutical company environment
- Time management
- Good self-organization, creativity and initiative.
- Flexible
- Team-player
- Accurate
- Effective communication skills (both written and oral).
- Ability to transmit knowledge to others
Language
- Spanish
- English (Reading, writing and speaking) -advanced level
**Who we are**
Organon delivers ingenious health solutions that enable people to live their best lives.
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