Regulatory Director Cover Letter

I am excited to be applying for the position of regulatory director. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for scientific leadership and transparency of internal regulatory compliance practices to stakeholders, both internal and external, to support regulatory agency and consumer confidence in Henkel’s products.

My experience is an excellent fit for the list of requirements in this job:

• History of working collaboratively across functions
• Regulatory experience with robotic medical devices
• Understanding of reimbursement requirements
• Immunology and biologics experience
• Expert knowledge of FDA and foreign regulations and guidelines
• Demonstrated experience in the preparation and submission of INDs, BLAs, NDAs
• Knowledge of GMPs, GLPs, GCPs
• Proficiency in MS-word, excel, PowerPoint, adobe

In response to your job posting for regulatory director, I am including this letter and my resume for your review.

In my previous role, I was responsible for tactical and strategic regulatory leadership to the organization and manages one or more regulatory programs, including: Continuous improvement activities, compliance related projects.

Please consider my qualifications and experience:

• A thorough knowledge of drug development and global regulatory requirements including the structure and content of regulatory submissions is necessary
• Prior regulatory experience across a diverse portfolio of products is preferred
• Demonstrated leadership participation with U.S. and international submissions
• Working knowledge of FDA EMA regulations, pharmacopeial requirements, the regulators, the regulatory approval process
• Excellent track record in building effective relationships with regulatory authorities
• Experience managing the assembly and messaging of all components of regulatory CMC submissions during development
• A strong record of successful submissions for biologics and drugs which include INDs, IMPDs, NDAs, MAAs, Annual Reports, Amendments, Supplements, DMFs
• Work cross functionally with clinical, quality, manufacturing, supply chain, marketing, commercial, and product management

I submit this application to express my sincere interest in the regulatory director position.

In my previous role, I was responsible for tactical and strategic regulatory leadership to the organization and manage one or more regulatory programs, including continuous improvement activities, compliance related projects and/or new product development.

Please consider my qualifications and experience:

• Demonstrated facilitative skills
• In-depth knowledge of government programs and the managed care industry and experience leading and managing regulatory affairs programs through teamwork, collaboration and open communication
• Intermediate proficiency in Microsoft Outlook, Word, Excel, PowerPoint, Project, Access, and Visio
• Project Management of a major marketing application submission
• Experience in validation of software systems and systems security and control (preference)
• Experience with computerized systems implementations, comprised of multiple application types, in a regulated environment
• Direct the Regulatory Affairs staff in the planning, preparation and submission of applications to the appropriate regulatory agencies for the approval or maintenance of animal health products so that all compliance requirements are met and licenses and registrations are attained in a timely manner
• Provide interpretive regulatory opinions, policy, guidance and strategies to ensure that development of new products result in expeditious approvals, meet regulatory requirements and fully exploit the capabilities of the new compound

I submit this application to express my sincere interest in the regulatory director position.

Previously, I was responsible for strategic direction in developing, implementing, and evaluating project plans, goals and timelines; manages regulatory compliance related development projects.

Please consider my qualifications and experience:

• Work with the Regulatory Reporting team to ensure that policy advice and regulatory reforms are appropriately interpreted
• Actively participate in advocacy initiatives either via direct response to rule makers or in conjunction with trade associations on all capital related items
• Ownership of monthly Significant Risk Transfer (SRT) governance
• Participate in ad-hoc projects in relation to consultations and new regulations
• CFA, FRM, MBA or Legal qualification
• Experience/Education in a quantitative field
• Strong interpersonal, written and oral communication skills, particularly in relation to conveying complex issues in a straightforward and concise manner
• Result-oriented with excellent attention to detail and a focus on accuracy of information

I am excited to be applying for the position of regulatory director. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for tactical and strategic regulatory leadership to the organization and manages one or more regulatory programs, including: Continuous improvement activities, compliance related projects and/or new product development.

Please consider my qualifications and experience:

• Communicates appropriately & effectively internally at all levels of the organization & with external stakeholders
• Obtains cross-functional alignment through effective communication
• Sets an example by their consistent professional behavior
• Experience in the cosmetics industry
• Technical role in a FDA-regulated environment is beneficial
• Prior experience in support or development of a certified quality system, ISO, is also preferred
• Regulatory affairs certification (RAC) or coursework is advantageous
• SHE, OSHA, EPA, DEP, air permits