Director, Regulatory Affairs - Pharma-Cruiting - Life Sciences Executive Recruiters

Position Description

Director of Global Regulatory Affairs, Richmond, VA

Report To: VP Clinical, Scientific and Regulatory Affairs

Territory: Focused primarily on US business located in Richmond, VA.

Scope of Responsibilities:
This person will responsible for directing, planning, and implementing all regulatory activities for products, line extensions, licensed products, etc. including experimental and commercial addiction, psychiatric and analgesic products. This will include regulatory strategies for new product registration and submission of appropriate regulatory filings. No New Chemical Entity (NCE) development is expected.

Toward that goal, areas of expertise will include:
Regulatory Planning
• Interpretation of rulings, policies, guidelines and regulations of FDA and other agencies as they relate to RB products and practices
• Advising on process validation and verification
• Assisting in designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials
Regulatory Development
• Assists VP CSRA, Global Pharmaceuticals Director, and Pharmaceuticals Director of Research in the review and analysis from a regulatory point of view licensing, acquisitions, and clinical research proposals for novel formulations and existing molecules submitted by others (e.g., CMC, IND, NDA and ANDA).
Ongoing Post-marketing Maintenance
• Assist in preparation of submissions and monitoring of applications submitted to the FDA
(e.g, 505 (B1 and B2) applications,
• Establishment, registration and maintenance of Drug Listing, DDMAC, Annual Reports, PSUR, Post-marketing surveillance reports, etc.)
Regulatory Compliance
• Insuring staff training and regulatory compliance
• Advising on or preparing and submitting annual reports
• Develop and implement Quality Systems to ensure compliance with regulations
• Evaluation of labeling, advertising and promotion from the standpoint of compliance with applicable (e.g., FDA rulings and policies).
• Facilitating recalls, safety alerts, or notices of failure to comply with regulations
• Crisis management and the development of Correction Action Plans in Response to 483s, Warning Letters, and Administrative Actions (e.g., seizures, embargos, etc.)
• Ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion

Essential Duties:
• Develops budgets for Regulatory Affairs and ensures compliance with approved budgets in coordination with VP Clinical, Scientific and Regulatory Affairs (CSRA).
• Ensures all aspects of regulatory affairs are properly planned and formulated and executed according to FDA regulatory requirements.
• Works with rest of business team to prepare development strategies leading to product labeling that fully exploits competitive advantages and enables advantageous promotional positioning.
• Responsible for coordinating and developing information and providing counsel to Manager Regulatory Affairs for reports submitted to the FDA.
• Ensures timely preparation of organized and valid submissions for business and regulatory review.
• Assists VP CSRA in copy clearance activities as necessary to ensure business objective and regulatory compliance.
• Ad hoc tasks as required by VP CSRA

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Candidate must possess:
• a complete and thorough understanding of the clinical, non-clinical, labeling and promotional/marketing aspects of the drug development process, as they apply to new drug development and registration maintenance activities
• a demonstrated ability to direct regulatory affairs efforts
• an ability to manage multiple projects and deliver results on timelines that support Company objectives
• skills in analyzing information and data, implementing procedure/methods, developing SOP’s, and decision-making and problem solving
• Excellent management, verbal and written communications, interpersonal, organizational and planning skills are required

Education/Experience:
• Doctoral degree (Ph. D., MD, or JD)
• Minimum 10-15 years of recent experience in the US pharmaceutical business with emphasis on multiple aspects of FDA laws and regulations. With experience in CMC, IND, NDA and ANDA preparation and documentation as well as regulations and policies of promotion and advertising of products.
• Experience with international regulatory agencies and CNS medications, especially opioids is a positive.

Please send your cover letter and resume to ruth@pharmacruiting.com

How to Apply

Application Instructions / Send a Resume