Director, Regulatory Affairs Cover Letter

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

Previously, I was responsible for strategic guidance regarding global regulatory requirements to UCells management team for all CMC regulatory matters in support of UCells product development.

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

• RAC certification is preferred
• Experience in other relevant functions will be considered
• Solid understanding of dossier requirements New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA)
• Leadership capabilities working across varied cultures, expertise and backgrounds
• Effective/appropriate delegation of authority and responsibilities
• High ethical standards for compliance to regulations and procedures is essential
• Initiative, combined with a high energy level is critical to success
• Regulatory experience preferred for therapeutic area of Oncology

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

In the previous role, I was responsible for regulatory guidance to the CMC department (e.g., stability protocols, specifications, report reviews, C of A’s, product labels, and CMC development plans).

Please consider my experience and qualifications for this position:

• Assist Development teams and Regulatory Senior Management in developing Regulatory strategies that are EU appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways, to expedite development
• Lead interactions with EU regulatory agencies at both national and central level, and assist internal teams in navigating such interactions
• Proven track record of supporting EU regulatory applications
• Utilize knowledge and past experience to review submissions to Regional HA to ensure regulatory compliance
• Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) to support filings
• Basic understanding of drug development (PK, PD, statistical concepts, data collection, endpoints)
• Knowledge of company policies and procedures in drug development and product maintenance requirements
• Demonstrated problem solving skills as applied to local regulatory issues

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

In my previous role, I was responsible for cMC regulatory affairs leadership, oversight and strategy in support of product assignments, including but not limited to CMC regulatory strategies, regulatory requirements in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

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:

• Excellent leadership, communication, interpersonal and collaboration skills
• Experience in labeling and artwork processes preferred
• Experience working with teams, driving consensus and results
• Experience in labeling and artwork processes and knowledge of regulatory systems preferred
• Expertise in labeling regulations
• Adobe Acrobat, Microsoft Office
• History of achieving regulatory goals in ambiguous and sometimes challenging situations
• Thorough understanding of g lobal regulatory environment and relevant drug development regulations and guidelines

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

In the previous role, I was responsible for specific regulatory environment intelligence, anticipate regulatory hurdles and strategic guidance to both Commercial Operations and Global Regulatory Affairs.

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:

• Demonstrated record of successful product commercialization using creativity in devising regulatory submission strategies
• Solid understanding of regulatory requirements interfacing with the FDA and working within an IVD company
• Understanding of CLIA regulations, laboratory practices/requirements
• RAC certification
• Experience developing and implementing successful global regulatory strategies
• Experience working with Health Authority
• Negotiate and obtain agreements on behalf of the company at meetings with regulatory agency officials at director levels or above
• Interact with and advise U.S. Product Supply Quality Assurance senior management in all matters concerning the FDA's oversight of the local manufacturing facilities

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

In my previous role, I was responsible for regulatory and scientific expertise to develop regulatory CMC strategies for biologics product development and commercialization.

Please consider my experience and qualifications for this position:

• Develop and implement strategy for early and late stage products to achieve regulatory approvals
• Collaborate closely with multiple departments in the company and also manage and provide guidance to staff as needed to support regulatory activities
• Relevant regulatory requirements
• Skilled within primary functions of legislative development, research, manufacturing and quality assurance
• Knowledge of systems for electronic storage and submission
• Knowledge of pharmaceutical generic industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
• Knowledge of domestic laws, regulations, and guidance that affect generic prescription products
• Pharmaceutical generic experience (ANDA) in establishing regulatory strategy highly preferred