Global Regulatory Affairs Cover Letter

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

In my previous role, I was responsible for regulatory leadership and advise on regulatory guidelines, policy, product specific regulatory issues and the regulatory climate.

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

• Solid QMS experience
• Moderate pharmaceutical industry experience
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions
• Basic working knowledge of drug development process and regulatory requirements
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects
• Drug Development - understands the phases, processes and techniques used within a drug development environment including protocol design and development
• Understands appropriate Competent Authority regulations and guidelines
• Good Clinical Practices (GCP) – understands good clinical practices and can apply to a research environment

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

In my previous role, I was responsible for guidance on drug and device regulations, regulatory strategy, and pharmaceutical and design controls/design history file deliverables to other combination product regulatory professionals.

Please consider my experience and qualifications for this position:

• Sound knowledge in natural sciences with a focus on biological medicinal products, ideally plasma-derived and recombinant products
• Hands’ on experience in pharmaceutical and or Diagnostic product registration in AP countries and in HA interactions
• Thorough knowledge of AP regulatory systems, regulations, clinical trials, and product registration requirements for Medical Devices, in vitro Diagnostics, and/or Pharmaceutical products
• Familiar with GCP and clinical laboratory regulations in AP region
• Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and /or Registration dossiers, including device registrations)
• Excellent verbal and written communication skills – proficiency in written and oral English and another language is preferred
• Able to educate a wide range of audience skill levels with different teaching techniques
• BS/BSc or BA accepted, PharmD preferred

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

In my previous role, I was responsible for appropriate Europe region regulatory input to project teams via the Global Regulatory Lead and Global Regulatory Teams, and ensures effective strategic input to Global Drug Development and Lifecycle planning in line with Corporate/Regional 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:

• Demonstrates problem-solving and interpersonal skills through effective interactions with team members and generates alternative solutions prior to elevation of issues to manager
• Experience as primary liaison to regulatory authorities and in handling Agency meetings
• Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
• Working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to a pharmaceutical research and production environment
• Applicable regulations, guidelines and regulatory processes
• Technical Leadership skills/understanding of managing people
• Participate in the quality verification of regulatory submissions
• International travel will be a feature of this appointment

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

Previously, I was responsible for support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy.

Please consider my qualifications and experience:

• Academic followed by Ph.D
• Profound knowledge of English speaking and excellent writing skills
• Strong and effective communicator and negotiator
• Sound understanding of or working experience with vaccine research, vaccine production, quality control or regulatory affairs is an advantage
• Experience in (veterinary) vaccine research, vaccine production or quality control is an advantage
• Thorough knowledge of regulations and guidances governing drugs and biologics in all phases of development in the US and EU, with a good understanding of basic regulatory requirements in emerging markets
• Demonstrated skills in complex reasoning and risk management assessments
• Excellent written, communication, project management and presentation skills (articulate and persuasive)

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

In the previous role, I was responsible for overall regulatory support, including developing regulatory strategies and timeline development, and prepare, submit and maintain chemical management regulatory filings (including renewals) to ensure compliance with relevant country regulations.

Please consider my qualifications and experience:

• Strong scientific and regulatory background with demonstrable experience of substantiating general wellbeing and/or health claims on retail food or beverage brands, ideally in multimarket or in tougher regulatory environments
• Previous experience working with innovation or R&D teams would be an asset
• Broad knowledge is preferred and covers scientific regulatory expertise
• Good working knowledge of the current global regulatory affairs environment
• For preference, experience across a range of product types (medicines, devices, foods, cosmetics, household goods, or other industries)
• Demonstrated collaborative skills, political awareness, diplomacy and superior interpersonal skill
• Working with internal and external EHSS policies, standards and practices
• Strong interactions with EHSS and Product Stewardship functions