Senior Director, Regulatory Compliance and Operations

We are seeking a strategic and hands-on Senior Director, Regulatory Compliance and Operations to lead and scale our global Regulatory Operations.

This is a newly created, build-and-scale role reporting into the SVP of Regulatory, Quality, and Medical Writing, and will be responsible for ensuring compliance excellence, operational efficiency, and technology enablement across the department.   The ideal candidate is a proven leader with deep experience in regulatory operations and medical writing processes and operational efficiency, complemented by a strong technical background, especially in Veeva Vault RIM, document management, process automation within regulated environments and quality management.   This role could be in-person or remote (if remote, occasional travel to the HQ office in Boston, MA, will be required).   Responsibilities    Define and execute the global regulatory operations strategy in alignment with corporate goals.

Lead and mentor teams across all functions to ensure operational efficiency, consistency, and compliance.  Serve as a key partner to PepGen leadership to support submissions, inspections, and lifecycle management activities.  Oversee global Regulatory Information Management (RIM) systems, including Veeva Vault RIM, ensuring data integrity, traceability, governance, and compliance.  Drive submission planning and execution (publishing, submission tracking, health authority communications).  Develop and maintain regulatory SOPs and work instructions, templates, training materials, and process maps to ensure operational excellence.  Maintain and enhance Quality Management Systems (QMS) in compliance with GxP and ISO standards.  Partner with Regulatory and Quality leadership to define and execute audit readiness initiatives (BIMO / PAI) and support regulatory inspections as needed.  Implement technology-driven process improvements using automation and analytics and promote a culture of continuous innovation.  Provide leadership oversight to the Medical Writing function to ensure high-quality, compliant, and timely deliverables (CSRs, CTD modules, labeling, etc.).   Partner with functional teams to ensure consistency, quality standards, and document management practices across clinical and regulatory documents.   Serve as the business owner for Veeva Vault RIM, regulatory publishing tools, and document management systems.   Champion digital transformation initiatives to enhance efficiency, transparency, and compliance in document lifecycle management.   Collaborate with IT and business teams to evaluate and implement new tools supporting regulatory and quality operations.   Liaise with vendors and external peers in the industry to stay current with evolving regulatory systems technology trends.  Requirements    Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field; advanced degree preferred.   12+ years of experience in regulatory operations / process / compliance within the biotech or pharma industry.   Proven track record in building and leading cross-functional operations teams in global, matrixed environments.   Hands-on experience managing Veeva Vault RIM, Veeva Quality Suite, or similar systems.   Strong understanding of global regulatory frameworks (FDA, EMA, ICH).   Excellent analytical, communication, and change management skills.   Demonstrated success in implementing process improvements and automation in regulated functions.   Experience supporting product lifecycle management and global submissions.   Passion for technology-driven compliance and operational transformation.   Compensation  The estimate full-time salary range for this role is between $239,000 to $305,000.

The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.     PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.   About PepGen PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.

PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics.

Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com.

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EEO Statement PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies PepGen does not accept unsolicited agency resumes.

The company will not be responsible for any fees related to resumes that are unsolicited.

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