Regulatory Affairs Manager Cover Letter

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

In my previous role, I was responsible for interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings.

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:

• Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential
• High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates
• Experience working under pressure on multiple tasks concurrently, manage those delegated
• Expertise and experience in regulatory affairs in the Biological, Pharmaceutical, or Medical Device industry
• Self-starter, pays close attention to detail, and possesses a “can do” attitude
• BS in bio/chemistry, microbiology, pharmacy or related engineering subjects
• A strong familiarity with parenteral products
• Previous experience with pharmaceutical CMC filings for INDs and NDAs

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

In the previous role, I was responsible for input on, review and approve product and labeling changes for compliance to standards, guidelines, regulations, and regulatory approvals/clearances; implement global regulatory action plans based on these changes.

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:

• Knowledge of regulatory affairs requirements
• Leadership / Management Experience Ideal
• Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging
• Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling
• Fluent in English, further languages are an advantage
• Experience in preparation for notified body audits and FDA inspections
• Presentation skills for small to mid-sized groups
• Strong experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality

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

In the previous role, I was responsible for cMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidances and directives, and evaluating and communicating their applicability to the development teams.

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

• Regulatory, CCRA or CCRP certification preferred
• Demonstrated leadership abilities through prior work experience
• Computer literate to include working knowledge of Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail applications
• Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
• Provide guidance to BG US on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents
• Provide regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols
• Knowledgeable of MDD and MDR, ISO13485, Q and, IDE, 510(k) premarket notification
• Regulatory Affairs Certification (US) through RAPS preferred

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

In the previous role, I was responsible for customers with product safety/regulatory information in accordance with US FDA/FEMA guidelines, customer specific guidelines and international regulations.

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

• Knowledge of the registration process, specific local regulatory requirements, BPFK environment including organisation, people and trends, regional regulatory development and collaborative initiatives
• Basic understanding of drug pharmacology, toxicology, clinical study requirements and procedures, and clinical study and safety aspects pertaining to product registration applications
• In depth experience of the pharmaceutical / biotechnology pharmaceutical or medical device industry
• Broad experience of Regulatory Affairs
• Experience in Change Control preferred
• In depth knowledge of local and European regulatory affairs legislation and guidance
• Experience in Animal Health Regulatory environment with demonstrable network of external key stakeholders
• Assertive confident credible communicator

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

Previously, I was responsible for oversight in the screening of Regulatory Consultants for suitability for sites prior to engaging them for the specific task to help sites to implement Quality Management Systems in compliance with relevant FDA and other Medical Device Regulatory.

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:

• Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices regulatory Compliance competency
• Significant use of computer keyboard, monitor, and mouse
• Working concurrently on several cross functional projects to meet business priorities will require effective time management and a broad base of personal and interpersonal effectiveness
• Team Oriented, yet self-motivate
• Experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process
• Proficiency in MS-Office (Word, PowerPoint, and Excel knowledge)
• Previous experience as a Regulatory Affairs Manager is preferred
• Prior experience in leading FDA inspections and Notified Body audits is preferred