Regulatory, CMC Business Process Specialist

Job Description

On behalf of our Regulatory Affairs-Chemistry, Manufacturing, and Controls (CMC) department, we are looking for a candidate to join our global team.

Regulatory, CMC Business Process Specialist

This position can be executed remotely or Hybrid from Portugal or from the United Kingdom

Purpose of the role

Under the guidance of the Associate Principal Scientist, Regulatory Chemistry, Manufacturing, and Controls (CMC) Business Processes Lead, you will provide support for the management and execution of regulatory CMC systems, processes, and CMC team training curricula. You will ensure business processes are developed, maintained, and training coordinated as required.

You gather, review, update, and report routine data and regulatory CMC-related information and maintain regulatory tools and databases on a routine schedule to ensure visibility into the status of regulatory activities. You will serve a key role as a subject-matter expert in their area of focus, while gaining exposure to end-to-end regulatory CMC information management and the drug development lifecycle.

Main responsibilities

• You will support the CMC scientists with the coordination and request of Certificates of Pharmaceutical Product (CPP) required as supportive documents for post-approval submissions to health authorities.
• You support the Organon tracking tool to manage responses to Health Authority questions.
• Furthermore, you will support the maintenance of the Organon Regulatory CMC training curriculum for CMC roles.
• You support the coordination and updating of Organon Regulatory CMC Standard Operating Procedures applicable to business processes and systems.
• Furthermore, you will be responsible for updating regulatory tools and databases on a routine schedule to ensure the timely delivery of assigned activities.
• Utilizes and maintains Organon Regulatory CMC systems to support compliant operational execution of activities related to CMC business processes, as needed. Conduct all activities with an unwavering focus on regulatory conformance.
• You assist in the development and continuous improvement of business processes, tools, systems, metrics, and analytics under the supervision of a manager.
• And you provide support for other CMC projects and activities, as required.

Your profile

• Bachelor’s degree in science, engineering, or a related discipline.
• At least one year of experience in the pharmaceutical industry in either pharmaceutical or biopharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Capability to effectively manage and deliver against multiple and potentially competing priorities.
• Ability to work effectively in matrix organizational structures.
• Demonstrated flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high-quality, compliant deliverables.
• Must have excellent interpersonal skills and a proven ability to communicate effectively in both a written and verbal format.
• Ability to influence and work both independently and collaboratively in a team structure.
• Exposure to regulatory affairs either through direct experience or via a role in research and development, quality, or manufacturing.
• Experience in regulatory systems.

What we offer

We welcome you to a truly global, dynamic, and challenging environment with excellent personal development opportunities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary
• Attractive collective health care and insurance packages
• Solid Pension Plan
• Annual bonus based on company performance.
• Numerous training, coaching, and e-learning modules for long-term job opportunities and development

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.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Employee Status:

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:

Requisition ID:R520703