Senior Manager, Regulatory Affairs Cover Letter

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

Previously, I was responsible for regulatory input into the content of non-CMC parts of dossiers such as Labeling, Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals.

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

• Oncology and/or rare disease experience strongly preferred
• Knowledge of EU, Canada, Japan regulations and processes desirable
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
• Considerable pharmaceutical industry experience
• Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role)
• Able to demonstrate skill(s) in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
• Effective manager who is able to bring working teams together for common objectives

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

In the previous role, I was responsible for regulatory leadership in promotional material review, data analysis and product labeling as related to registration and commercialization of medical devices and in-vitro diagnostic products.

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:

• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset
• Act as the point of contact for Regulatory Agencies for asset(s)
• Assess the regulatory impact of Regulatory Process Changes pertaining to approved commercial products
• Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s)
• Ensure planning and proper organization of activities (for of regulatory affairs specific activities within technical/nonclinical or procedural) in line with the overall project plan and regulatory affairs milestones
• MSc in Pharmacy, Chemistry, Biology, Medicine, or similar discipline
• Experience with Program Management – Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving
• California license as a Clinical Laboratory Scientist or Immunohematology limited license

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

In the previous role, I was responsible for input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

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 managing relationships with CROs and/or contractors preferred
• Previous proven experience in pharmaceutical Regulatory Affairs, with previous experience in the Oncology therapeutic area preferred
• Previous above country / regional experience - ideally in the major EU countries
• Recent experience of leadership within Centralised Procedures
• Strong leadership presence and solution driven style
• Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes and regulations
• Operational knowledge of IND and/or BLA regulations and experience in US regulations pertinent to product development
• Pharmaceutical development or regulatory affairs experience with biologics preferred

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

Previously, I was responsible for guidance to marketing, product development, package engineering & regulatory personnel regarding label content, ensure that product labels & labeling comply with US & foreign government regulations.

Please consider my experience and qualifications for this position:

• Strategic Leadership – Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US
• Program Management – Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving
• Interact with (or represents his/her area/product at) internal project related teams, for all parts of regulatory affairs aspects of a given project on technical/nonclinical/clinical or procedural aspects
• Participate in project/product-related discussions and provide strategic, scientific and regulatory affairs input, for all parts of regulatory affairs aspects of given project on technical or procedural aspects
• Provide support to the GRL via authoring, input and/or critical review of specific sections (technical/nonclinical and/or procedural) of regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries
• Coordinate (for specific (technical/nonclinical 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
• For cross-product sections or stand-alone documents work with the functional regulatory groups to ensure content is aligned with targeted overall profile of the product
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/nonclinical and/or procedural) and ensure that those documents meet regulatory requirements

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

Previously, I was responsible for regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices.

Please consider my qualifications and experience:

• Operational knowledge of IND and/or BLA regulations and experience in US regulations pertinent to product development and post licensure life-cycle maintenance activities
• Road-based regulation/standards background and current understanding of RA trends and guidances
• Strong communication (verbal, written, listening)
• Proficient in pharmaceutical technical writing such as SOPs, reports and regulatory submissions
• Experience reviewing technical documentation and reports
• Proficient in Microsoft Word, Visio, Excel and Adobe Acrobat
• Able to understand scientific, medical and manufacturing disciplines
• Higher education (educational background in pharma or bio-engineering is a strong advantage)