Manager Regulatory Affairs Cover Letter

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

Previously, I was responsible for technical guidance and training to Regulatory Operations staff: during strategy formulation, submission preparation and development of labeling, marketing or promotional materials, and in training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.

Please consider my experience and qualifications for this position:

• FDA, ICH and other relevant CMC/Quality and cGMP guidance documents
• Writing regulatory and scientific documents
• General regulatory and scientific knowledge of drug development
• Experienced performing Quality Assurance audits
• Senior Product Specialists
• Sales Adm
• Regulatory Affairs Certification or other regulatory training certificates or degrees are desirable
• Previous Regulatory Affairs Specialist Experience including Pre-Submission, IDE, PMA and 510(k) Submissions, CE Mark and other countries

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

In the previous role, I was responsible for regulatory guidance on product design and development plans (labeling, preclinical, and clinical studies), and utilization of standards.

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:

• Proven expertise in regulatory affairs, including, strategy planning, submission preparation, all phases of FDA regulations, global regulatory requirements and procedures, negotiations, product design and development systems
• Manage and provide collaborative support for execution of global change control strategies to US and other regions (EU & International)
• Manage and support various compliance submissions, including but not limited to Annual and Lot Distribution Reports
• Quality system support and Tech Ops liaison
• B.S / M.S in biochemistry, biology, engineering or related pharmaceutical field
• Knowledge of international medical device / drug regulations
• Experience with pre and post market activities including, but not limited to, Investigational Device Exemptions, premarket notification applications [510(k)], premarket approvals [PMA], technical files, procedures packs, and design dossiers
• Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations

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

In the previous role, I was responsible for strategic input on updates to FDA approved labeling for current marketed products and proposed labeling for products in development (pre-launch) in the capacity as the ad hoc US Regulatory Ad/Promo labeling representative on relevant Labeling Committee project teams.

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 successfully securing a number of FDA clearances and approvals
• Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
• High level of proficiency with MS Word and Adobe DC for document preparation
• Builds partnerships and mutual respect with regulatory authorities
• Comfort with utilizing Systems/ Database
• Working knowledge of NDA/ OTC monograph (topical) drugs, Class I & II devices, commodities & cosmetics
• Review new legislation and prepare detailed summaries on its impact to the company
• Complete Drug (NDC) and Device (FURLS) listings for assigned products

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

In my previous role, I was responsible for regulatory Strategy and Global Labeling colleagues with input into clinical study designs and labeling claims that will support commercial objectives.

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:

• Process improvement or audit experience is preferred
• Skilled in collaborative management of professional staff
• Knowledge of standards or controls management, preferably from a Managed Care Organization
• Proven success in developing and implementing new practices and controls (with specific improvements)
• Working knowledge of health plan environment is preferred
• Strong analytical and statistical skills and attention to detail
• Leadership competences -experience in team management is an asset
• Previous experience in healthcare, pharmaceutical or clinical setting

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

In the previous role, I was responsible for regulatory support to development and/or revision of product labeling (e.g., local labeling) in accordance with Brazilian requirements and in alignment with company policies and standards.

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:

• Superior written, verbal, interpersonal communications
• RA Certification preferred but not a requirement
• Previous experience applying this knowledge to the development of a regulatory/quality organization conducting nonclinical and clinical studies manufacturing development efforts
• Demonstrated capabiblity of applying this expert knowledge to complex technical problems with minimal supervision
• Experience in assessing compounds for further development efforts, identifying and ensuring the appropriate IND-enabling studies are conducted, interfacing with the FDA to solicit advise/present development results and author/review and approve documents suitable for submission in the eCTD format
• Regulatory compliance plans
• Regulatory submission management/coordination
• Complete higher education in the areas of sciences such as chemistry or pharmacy