Regulatory Affairs, Senior Specialist/Manager

2+ years

Not Disclosed

Remote, USA

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description:
Ergomed PLC is a rapidly expanding, full-service mid-sized Contract Research Organization (CRO) specializing in Oncology and Rare Diseases. Since its founding in 1997, the company has grown steadily through strategic investments and acquisitions, with operations across Europe, North America, and Asia.

At Ergomed, we foster a culture of visibility, creativity, and career development, giving employees a voice in shaping the company’s future. Our international culture thrives on collaboration, and we place great importance on employee well-being and mental health, understanding that a healthy work-life balance is key to high-quality service and client satisfaction.

Join us in our mission to make a positive impact on patients' lives.

Job Description:
Ergomed is looking for experienced Regulatory Affairs professionals with expertise in managing complex global clinical studies. This opportunity is open to candidates worldwide, but applicants must have excellent English communication skills and a strong understanding of the clinical trial environment and ICH GCP.

Key Responsibilities:

Lead and manage medium to high-complexity projects, ensuring effective coordination of SSU/regulatory tasks. Ensure the team meets targets while complying with agreed procedures, templates, and trackers.
Develop strategy and manage set-up activities, including SSU RA Management Plans, procedures, and core documents, ensuring compliance with department standards. Support team members in strategy preparation, identifying issues, and providing resolutions.
Contribute to or author complex technical, scientific, and legal documentation.
Oversee the preparation, collection, and review of regulatory information and documents for submissions to FDA, EMA, and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs), as well as Ethics Committees/IRBs for initial authorization and maintenance.
Provide expert regulatory advice to clients on complex queries and ensure consistent, high-quality guidance across regions.
Tailor communications with regulatory authorities and Ethics Committees/IRBs to meet specific requirements, using alternative resources when possible.
Monitor project budgets, track time spent vs. budgeted, and escalate any issues as needed.
Contribute to securing new and repeat business by supporting Business Development Managers (BDMs) and reviewing regulatory proposals, costing, and budgets.
Provide training, coaching, and mentoring to junior staff members.

Qualifications:

Bachelor's Degree in Chemistry, Life Sciences, Medicine, or a related field.
Minimum of 3 years’ experience in the CRO industry.
Proven track record in successfully managing global regulatory projects.
Expert knowledge of ICH GCP and/or GVP, with a comprehensive understanding of global regulatory requirements.
Strong written and verbal communication skills, with the ability to present information clearly and concisely.

Additional Information:
At Ergomed, we prioritize diversity, equity, and inclusion by fostering an equal-opportunity workplace where individuals from all backgrounds, genders, and ages can thrive. We believe that our people are our greatest strength, and by working together with a human-first approach, we continue to improve the lives of those we serve.

What We Offer:

Competitive salary
Opportunities for rapid career growth within a dynamic and fast-growing company
A multicultural environment with English as the company language
Strong emphasis on personal and professional development
A friendly, supportive working environment

#LI-Remote

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Regulatory Affairs, Senior Specialist/Manager

Job Description

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