Regulatory Affairs Project Manager Cover Letter

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

In the previous role, I was responsible for guidance & advice on local country regulatory environments; provide assessment of the impact of new and changing regulations/ requirements.

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 Rx labeling preferred
• Prior participation on standards working group(s) is preferred
• In-depth knowledge of U.S. and EU regulations and a firm awareness of key industry standards basic to a medical device manufacturer, with functional understanding of international device regulations preferred
• Understanding of combination products and their respective regulations is preferred
• Experience in due-diligence evaluations of companies and/or product acquisitions are preferred
• Knowledge of drug regulation and GMP is preferred
• BSc in life sciences or equivalent qualification/experience
• Obtain international market access for our innovative interventional X-Ray devices and related software, by defining smart clinical and regulatory strategies, and by first time right submissions to the FDA, Notified Body in Europe, and Health Canada

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

In my previous role, I was responsible for operations Regulatory and AZ technical functions clear, concise guidance on current CMC regulatory requirements in assigned regions to support business tactical or strategic decision-making.

Please consider my experience and qualifications for this position:

• Coordinate (for specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy
• May act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
• Ensure planning and proper organisation of activities (for of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones
• Experience with at least one major marketing application (NDA/BLA/MAA/JNDA )
• Global regulatory lead experience is not essential but would be beneficial
• Experience working with the Life Sciences, CRO or Consulting Industries
• Basic knowledge of regulatory legislation and guidelines

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

In my previous role, I was responsible for regulatory advice and guidance to EMEA business leadership and support functions to ensure products and services meet regulatory requirements.

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 in orthopedic or medical device strongly preferred
• Software IEC 60601 experience preferred
• Requires a strong working knowledge of US, EU, Canada, and Australia/New Zealand regulations that affect Class I, II and III devices
• Results oriented, positive “can do” attitude
• Continuously develops the talents of self for current and future business needs
• MS Project Server experience helpful
• Expert knowledge of the Canadian Food and Drugs Act and Medical Devices Regulations (SOR/98-282) along with relevant policies and guidance documents applicable to the regulation of medical devices/IVDDs in Canada
• Excellent verbal, written, research and presentation skills

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

In my previous role, I was responsible for cMC regulatory guidance, both internally and externally (CMOs), regarding CMC changes such as analytical changes, specification changes and manufacturing changes and their impact on regulatory filings with guidance.

Please consider my qualifications and experience:

• Superior computer literacy and keyboarding skills (MS Office, validated EDM systems, Trackwise)
• Effectively prioritize and complete multiple projects within established timelines
• Completion of Post Graduate certification in Regulatory/QA preferred
• RAC (CAN) (Regulatory Affairs Certification) preferred
• Working knowledge of Health Canada regulations, guidance and policies, including a high level understanding of the Health Canada regulatory requirements for clinical submissions
• Driven to achieve a high level of accuracy and quality in work
• Interact with (or represents his/her area/product at) internal project related teams
• May fulfil the role of N+1 review as per RSBP

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

In the previous role, I was responsible for cMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develop CMC regulatory strategies for product development, including technical documentation and change controls.

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

• Basic understanding of the regulatory aspects at various stages of development, from EIM to post-approval activities
• Familiarity with clinical trial methodology and statistics
• Capable of working independently effective team player
• Extensive knowledge of US, European and international regulations and regulatory requirements
• Extensive knowledge of medical device industry standards and guidance documents
• Progressive project management experience in at least one discipline (RA, R&D, Operations, PMO)
• Demonstrated expertise in the effective application of project management tools such as MS Project, SharePoint, and Visio
• Knowledge of the Quality System Regulations (21 CFR) and Medical Device Directives (MDD) and other regulations related to Pre Market Clearance/Approval