Regulatory Lead Cover Letter

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

In my previous role, I was responsible for regulatory input in support of product development, ensuring regulatory requirements are communicated and elevated, where appropriate.

Please consider my qualifications and experience:

• Strong interaction with leadership in global regulatory affairs and development functions and senior business unit leadership
• Systems/applications needed to support the Regulatory Affairs function of a pharmaceutical company
• Business process, architecture and analytical skills across the e2e Pharmaceutical landscape
• Project management practices and methods, including Help Desk systems and controls
• Research and Development, and Regulatory systems knowledge
• Tertiary or higher qualification in biological or agricultural sciences
• Experience in Stewardship
• BS in chemistry or toxicology (or a closely related scientific field)

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

Previously, I was responsible for input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval.

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

• Understand how to create and refine process that involve data, people and complex decision-making
• Comfortable in a fast-paced, new, technology-driven environment
• Good regulatory and/or technical writing skills
• Excellent understanding of study financial management
• Potential for frequent travel
• Establish Regulatory Control Framework and support/challenge regulatory programmes to ensure key criteria are satisfied prior to and including transition to BAU
• Deep experience of Regulatory Affairs and Quality Assurance within the Pharmaceutical industry
• Overall responsibility for the management of the Regulatory Affairs (RA) function in the Shire France-Benelux country cluster

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

In my previous role, I was responsible for guidance on regulatory requirements to product development teams to facilitate compliance and develops effective strategies for regulatory submissions / documentation.

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:

• Educating and influencing at different levels of the organization
• Chemical background to understand the CIS products
• Filing PMN’s, working with SDS’s, breadth of experience with other regulations (e.g., DOT, customs, Food Contact or Personal Care Products)
• Relationships with regulators
• Managing relationships with customers
• Managing external consultants
• Understanding of chemical regulations in other countries
• Working with the business and communicating regulatory needs in business terms

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

In the previous role, I was responsible for regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines.

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:

• Communicating with colleagues for whom English is a second language
• Developing and implementing regulatory processes &/or integrating regulatory issues into business processes
• Managing regulatory issues in SAP
• Clear understanding of decision rights around regulatory issues, when regulatory should say no and when regulatory should explain the implications of decisions and help, but allow the business to make the decision
• Experience with quality reporting and regulatory oversight in a health plan setting, including NCQA, state-specific audits, HEDIS, QARR, and CAHPS
• Previous experience interacting with auditing agencies and regulatory entities that are involved in health insurance
• Work experience leading large projects and delegating across internal teams
• Experience drafting and operationalizing policies and procedures

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

In the previous role, I was responsible for regulatory leadership and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage development and/or licensed in 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:

• Foster and maintain relationship and communication with the Regulatory Authorities in France
• Appoint delegate pharmacists (PR intérimaires)
• Thorough understanding of the drug development process, Shire’s Business model and International business and BU goals
• Good sense of urgency, judgment and strong team player
• Promotional materials and patient support materials on Shire products according to national advertising law and applicable codes of practice
• Coordinate the creation of prescribing information for new products
• Ensure appropriate contract and oversight is in place in case such activities are delegated to external regulatory consultants
• Integrity, and strong commitment to regulatory compliance and doing the right thing