Regulatory Strategy Cover Letter

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

Previously, I was responsible for clinical/nonclinical regulatory support for preparation, submission, management and maintenance of domestic and international regulatory submissions including: INDs/CTAs and amendments; global Marketing Applications (MAs) and amendments/supplements; Orphan drug applications; Expedited review requests; Post-marketing requirements/commitments and Annual Reports.

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:

• Develop partnerships with Key Affiliates and distributors, on site visits
• Identify and assess regulatory risks associated with the execution of regulatory strategies in assigned region
• Keep abreast of changes in regional legislation
• Lead preparation and represent the company at relevant external meetings
• Lead, manage and develop more junior team members
• Work with Global policy team to ensure monitor and analyze appropriate regulatory agency activities for assigned region, and assess impact on programs
• Experience supporting training and development of other team members
• Work closely with senior IRP Business Leaders to understand their franchises and existing regulatory workflow

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

Previously, I was responsible for customer support beyond BASF for end user drug product or formulation development, preparation of their application, and RA strategies for first filing or response to application deficiencies with major regulatory agencies.

Please consider my qualifications and experience:

• Skilled in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working with many cultures and time zones
• Overall strong relationship management, leadership and interpersonal skills
• Prior experience working with product launches of regulated materials in global environment
• Familiarity with foreign regulations of adverse drug event reporting requirements
• Previous well demonstrated experience in supporting senior business leaders
• First class time management, organisational and multi-tasking skills
• Intermediate-Advanced Word, Excel and Power Point skills
• A natural style of connecting with people and building great relationships

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

In the previous role, I was responsible for regulatory strategy leadership and consultancy to support the development of optimum strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology client goals.

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

• Develop a deep understanding of broader regulatory requirements, methodology, and internal implementation
• Work closely across multiple stakeholder groups to develop recommendations that will enhance efficiency, improve accuracy, and establish appropriate process controls across all asset classes
• Implement key process improvement recommendations
• Partner with Regulatory Strats to optimize workflow and industrialize Regulatory Analysis & Execution
• Strong experience with process implementation and improvement
• Robust academic background with demonstrated interest in a diverse set of subject areas
• Solid interest in financial markets and products
• Previous experience with securities-related regulatory policies (e.g., Volcker, CCAR) would be a bonus

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

In my previous role, I was responsible for clinical/nonclinical regulatory strategy and content to support preparation, submission, management and maintenance of domestic and international regulatory submissions including: INDs/CTAs and amendments; global Marketing Applications (MAs) and amendments/supplements; Orphan drug applications; Expedited review requests; Post-marketing requirements/commitments and Annual Reports.

Please consider my qualifications and experience:

• Experience with advanced statistical analysis also a bonus
• In-depth knowledge of health authority labelling regulations in Europe, US, and ROW
• Knowledgeable about health care delivery and/or health insurance and have the intellectual capacity to learn quickly about aspects of regulations with which he or she is not familiar
• An excellent oral communicator with experience speaking to large groups and to smaller audiences of policy makers and business leaders
• Strong experience with CTD format and content regulatory filings
• Delivery of at least one major application (NDA/BLA/MAA/JNDA )
• Make decisions on all key development questions as member of the project team (as all decisions impact the Regulatory dossier and approval processes, preclinical and clinical study and program designs, licensing)
• Working knowledge of foreign regulations of adverse drug event reporting requirement

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

Previously, I was responsible for regulatory guidance and assistance to clients in a timely manner regarding scientific and regulatory problems, issues, concerns, questions, and strategies associated with the drug development process.

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:

• Preferred experience in managing multiple filings resulting in first-time approval
• Preferred experience in managing personnel
• Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as the issues relate to regulatory requirements and strategy
• Show knowledge of the financial services industry, products, services and structure
• Be fluent in French and English, German would be considered as an asset
• Attention to detail, demonstrating initiative to investigate irregularities in data and commitment to high level of accuracy
• Demonstrated experience with Duke financial systems and processes
• Familiarity with rate-making concepts