Associate Director, Regulatory Affairs Cover Letter

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

In my previous role, I was responsible for regulatory expertise across preclinical and clinical research, CMC, and product development support, for small molecules, biologics, cell and gene therapies, drug/device combination products and medical devices.

Please consider my qualifications and experience:

• Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential
• MS in biology, animal science or other related science
• PhD or DVM desirable
• Veterinary clinical experience will also be considered
• Thorough understanding of US labeling regulations
• Solid knowledge of the drug development process
• Excellent communication (oral, written) and presentation skills necessary for interaction with cross-functional product labeling teams
• Knowledge of FDA advertising and promotion regulations and guidance is necessary

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

In my previous role, I was responsible for support to new product development projects, including input to business acquisitions, guidance for regulatory requirements in design development, labeling, and technical dossier preparations.

Please consider my qualifications and experience:

• Either biologics or small molecule experience
• Filing CTA and protocols amendments
• Demonstrated strategic regulatory influence, as well operational excellence
• Demonstrate an entrepreneurial approach
• Ideally recent experience with initial submission for a MAA with EMA/CHMP
• Working in cross functional teams to meet the milestones of EMA, including management delivery of the interactions
• Courage in communicating regulatory decisions and/or risks which will be met with resistance by key stakeholders
• Develop and execute strategies for new products (primary care) and across product life cycles

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

Previously, I was responsible for input from a global perspective on the CMC data required to support a clinical development program.

Please consider my qualifications and experience:

• Understanding of, and experience with, regulatory framework applicable to interactions with healthcare providers, payers, advocacy, and other business partners
• Activities, including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents)
• Participate as an active member of a multi-disciplinary team to establish development of Regulatory CMC strategies for commercial products, late, and early stage development programs
• Manage EU, US , International commercial license maintenance
• Provide in-depth reviews of protocols, reports, presentations, and documents
• Manage CMC related regulatory agency interactions
• Coordinate the preparation and timely submission of responses to regulatory agencies
• Act as primary regulatory CMC representative at internal meetings support at meetings with business partners and regulatory agencies for CMC related issues

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

In the previous role, I was responsible for updates on regulatory submissions and provide clinical, non clinical and CMC regulatory strategies for product development.

Please consider my qualifications and experience:

• Expertise in labeling regulations and arkwork processes
• Adobe Acrobat, Microsoft Office, Docu-Proof experience
• Strong scientific knowledge and regulatory experience applicable to the role
• Regulatory experience in drug development and commercialization
• Strategic thinker and problem-solver capable of providing advice, identifying risks, making informed decisions, and implementing plans and risk mitigation strategies
• Thorough understanding of global drug development regulations and guidelines
• Experience in managing, mentoring and developing direct reports
• Experience of working through the Centralised Procedure -- this can be at any stage

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

Previously, I was responsible for strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.

Please consider my qualifications and experience:

• Troubleshoot and resolve any problem on the critical path to product registration and life cycle maintenance
• Provide regulatory support, guidance and expertise to internal groups to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products (primary care) are developed in compliance with appropriate regulations and guidelines
• Manage centralized procedures, work in conjunction with regional subsidiary staff for decentralized procedures and provide critical assistance for national submissions in the above-mentioned region
• Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills
• Knowledge/experience of EU regulations, guidelines and regulatory processes for new chemical entitiess and product life cycle maintenance
• Experience in leading Health Authority meetings (FDA, EMA, Health Canada and others) is preferred
• Expertise in Excel and TeamSpace
• Personnel Management/Coaching/Mentoring skills