Regulatory Compliance Specialist

Job Title : Regulatory Compliance Specialist

Location : Greenville, NC (Onsite)

Experience : 7+ years

Duration : 12+ Months

Position Overview :

We are seeking a highly skilled Regulatory Compliance Specialist to lead compliance and quality initiatives within our pharmaceutical manufacturing environment. The ideal candidate will have extensive experience with FDA, EMA, and HMRA regulations and a strong background in bracketing and matrixing strategies.

Key Responsibilities :

Lead coordination between site and global teams to ensure alignment of SOPs and bracketing strategies.

Provide regulatory and technical guidance to maintain compliance with FDA, EMA, and HMRA requirements.

Develop and defend bracketing justification for multiple production lines, including 4 traditional lines, 1 RABS, and 9 isolators.

Facilitate governance meetings, escalate risks, and communicate status updates to site and global leadership.

Review, approve, and finalize protocol templates, summaries, and reports.

Requirements :

Bachelor's degree in a relevant field (pharmaceutical, life sciences, or related).

Minimum of 7 years of experience in the pharmaceutical industry, preferably in FDA-regulated manufacturing environments.

Proven experience in developing bracketing and matrixing strategies for pharmaceutical products.

Strong knowledge of FDA, EMA, and HMRA compliance requirements.

Working knowledge of cGMP and facility / equipment validation standards.

Excellent written and verbal communication skills with the ability to present complex information clearly and persuasively.

Demonstrated ability to work effectively across all levels of the organization and as part of cross-functional teams.

Strong problem-solving skills, critical thinking, and meticulous attention to detail.