Regulatory Affairs Sr/Mgr (Cmc)

About Biopeptek Pharmaceuticals: Biopeptek Pharmaceuticals is a leading Contract Development and Manufacturing Organization (CDMO) specializing in peptide therapeutics. We offer comprehensive peptide services, from early development to commercialization, maintaining the highest standards of quality and compliance.

: We are seeking an experienced CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs Manager or Sr RA (CMC). The ideal candidate will be proficient in preparing and filing Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) and have a deep understanding of the regulatory landscape.

Responsibilities:

Develop and implement regulatory CMC strategies for the development and lifecycle management of peptide products.

Prepare, review, and submit high-quality CMC regulatory submissions, including DMFs, to the FDA and other health authorities globally.

Coordinate with cross-functional teams for the timely preparation of CMC sections of regulatory documents.

Maintain an updated understanding of global regulations, guidelines, and standards, and communicate necessary updates to relevant teams.

Provide regulatory CMC advice and guidance to project teams and senior management.

Engage directly with regulatory agencies on CMC matters to ensure resolution of issues and progression of applications.

Review and approve change controls, deviations, and validations related to CMC.

Participate in the preparation for regulatory inspections and audits.

Ensure all regulatory submissions and approvals align with project schedules.

Oversee the preparation and maintenance of DMFs to ensure continuous compliance with FDA requirements.

Requirements

Qualifications:

Bachelor's degree in a relevant scientific discipline preferred; advanced degree preferred.

Experience in regulatory affairs, with a specific focus on CMC within the pharmaceutical industry.

Proven experience in preparing and filing DMFs with the FDA.

In-depth knowledge of global regulatory guidelines and procedures, especially FDA regulations related to CMC and DMFs.

Exceptional attention to detail and the ability to handle multiple projects simultaneously.

Excellent verbal and written communication skills, with the ability to interface effectively at all levels of the organization and with regulatory authorities.

Proficient in Microsoft Office suite and regulatory information management systems.

Benefits

Benefits

For employees:

• 80% employer-paid MEDICAL HMO plan
• 80% employer-paid VISION plan
• 80% employer-paid DENTAL PPO plan

For dependents: we pay ~ 40% of the above

• We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability
• We will eventually also add a Medical PPO plan
• 4% match 401k

PTO: 15 days total (vacation/personal days) + 5 sick days + holidays

Benefits are subject to change: What we pay is subject to our decision and can change at any time and for any reason, with or without notice.