Director Regulatory Cover Letter

Please consider me for the director regulatory opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for cMC regulatory advice and develop position papers to support the product development activities as well as CMC regulatory strategies.

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

• Oncology, Immunology and biologics experience preferred
• Substantial experience in regulatory affairs in one major country/region (eg
• Particular expertise for regulatory considerations for FIH/Phase 1 studies to support data generation for decision making and further development for novel agents
• Proven experience with electromechanical medical device regulatory requirements and submissions, including software
• Exhibits comprehensive expertise in global regulations regarding the manufacture and distribution of medical devices and/or combination products
• Knowledge and experience with GCP, GLP and QSR
• Expertise in pre-clinical studies, clinical trial design, project management, and negotiations with regulators
• Ensures advertising and promotion of products conforms to the requirements of the specific market

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

In the previous role, I was responsible for regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative therapies.

Please consider my experience and qualifications for this position:

• Strong problem solving, time management and prioritization skills
• Be confident in dealing with individuals at all levels of seniority
• Capable of building and maintaining relationships across the bank at all levels
• Able to produce formally written regulatory policy analysis presenting the formal view of the team on a given policy matter
• Solid knowledge of the Basel capital requirements as implemented in the US (US Basel 3/US FED rules)
• Knowledge of businesses and associated processes and controls
• Expertise in global labeling and managing project teams including international teams (not in the same time-zone)
• Biologics and rare disease experience is desirable

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

Previously, I was responsible for regulatory direction for the coordination, and preparation of CMC regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines.

Please consider my qualifications and experience:

• Strong leadership and influencing skills, particularly in situations where direct manager authority does not exist
• Experience building a high performance team, managing the performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization
• Expert knowledge of regulatory policies, practices and systems
• Expert knowledge of regulatory-related practices and standards
• Solid working knowledge of relevant domestic and global regulations and guidance
• History of successful interactions with global regulatory authorities
• Energetic, self-motivated and a hands-on professional with a strong work ethic
• Prior experience in leading major health authority interactions (e.g., FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings)

Please consider me for the director regulatory opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for guidance for regulatory CMC aspects of product development projects concerning EU and International country regulations.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• In-depth knowledge of medical procedure, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials
• Intricate knowledge of federal health care laws and regulations (such as Medicare, Medicaid and Tri-care)
• Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA/NDA/MAA)
• May be Director or Senior Director, based on experience
• Interpretation of global regulations governing medical devices
• The individual will have prior regulatory experience of project leadership, negotiation with and conduct of meetings with the FDA and preparation of IND and NDA submissions leading to product marketing authorization
• Act as subject matter expert on assigned regulatory matters
• Tracking of regulatory changes issued by supervisory authorities such as the US FED, PRA and BCBS

I would like to submit my application for the director regulatory opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for cMC regulatory support, guidance and expertise to internal and external groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.

Please consider my qualifications and experience:

• Advanced regulatory affairs training preferred – MS, RAC or other professional certification
• Expert knowledge of current EU regulatory requirements essential
• Expert understanding of CTD modules
• Good knowledge of TA assigned
• Effectively manages people & encourages them to seek development opportunities
• Proven as an effective leader
• Significant experience of leading complex regulatory submissions including MAAs
• Escalates issues appropriately & understands how far issues should be escalated