Willing to relocate: No, but willing to discuss a mutually agreed schedule of traveling to the office (e.g. once a quarter)
Key experience as regulatory lead: IND, CTA, and sNDA filings, responses to FDA and global health authority queries, orphan drug applications, substantial amendments
Résumé/CV: please email for CV
Email: dyhndz [at] gmail [dot] com
Hi, I am a highly motivated and business-minded regulatory affairs professional with diverse experience seeking employment at a biotechnology or pharmaceutical company. I am open to clinical regulatory strategy roles at a variety of company types and therapeutic area focus, including traditional pharma and AI-based biotech startups alike, just to name two differing examples.
My experience is spread across the biotech startup space, top 10 big pharma, government laboratory, and a contract research organization. Most recently, I functioned as regulatory strategy lead at the mid-senior level for a small molecule anti-seizure medication. I would be happy to discuss how my abilities as a regulatory strategy lead and varied experience in the biopharma field could contribute to advancement of your product pipeline, mesh with your current teams and style of regulatory affairs, and add value to your company.
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. once a quarter for a week)
Primary expertise and experience: Solution development, value proposition development, cross-functional & multinational team collaboration and management, FDA regulatory affairs (with EMA and PMDA familiarity), project management, stakeholder management
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I also have a graduate level academic background in biochemistry. I have collaborated with cross-functional teams and subject matter experts to develop product regulatory development support solutions and value propositions for over 160 biotech and 5 international pharmaceutical companies.
My goal is to take my experience developing support solutions for drug and medical device sponsors and apply it by working for a sponsor or other company directly, utilizing my end-to-end drug development and regulatory knowledge as well as solution development and management expertise to contribute to the company's mission. I am also interested in & open to roles within the tech/SaaS space, among a variety of others that employ any of my listed skills. Thanks!
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. once a quarter for a week)
Primary expertise and experience: Solution development, value proposition development, cross-functional & multinational team collaboration and management, FDA regulatory affairs (with EMA and PMDA familiarity), project management, stakeholder management
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I also have a graduate level academic background in biochemistry. I have collaborated with cross-functional teams and subject matter experts to develop product regulatory development support solutions and value propositions for over 160 biotech and 5 international pharmaceutical companies.
My goal is to take my experience developing support solutions for drug and medical device sponsors and apply it by working for a sponsor or other company directly, utilizing my end-to-end drug development and regulatory knowledge as well as solution development and management expertise to contribute to the company's mission. I am also interested in & open to roles within the tech/SaaS space, among a variety of others that employ any of my listed skills. Thanks!
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. once a quarter for a week)
Primary expertise and experience: Solution development, value proposition development, cross-functional & multinational team collaboration and management, FDA regulatory affairs (EMA and PMDA familiarity), project management, stakeholder management
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I also have a graduate level academic background in biochemistry. I have collaborated with cross-functional teams and subject matter experts to develop product regulatory development support solutions and value propositions for over 155 biotech and 5 international pharmaceutical companies.
My goal is to take my experience developing support solutions for drug and medical device sponsors and apply it by working for a sponsor or other company directly, utilizing my end-to-end drug development and regulatory knowledge as well as solution development and management expertise to contribute to the company's mission. I am also interested in & open to roles within the tech/SaaS space, among a variety of others that employ any of my listed skills.
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. once a quarter for a week)
Primary expertise and experience: Solution development, value proposition development, cross-functional & multinational team collaboration and management, regulatory affairs including de novo IND and BLA filings, project management, stakeholder management
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I also have an academic background in biochemistry. I have collaborated with cross-functional teams and subject matter experts to develop product regulatory development support solutions and value propositions for over 155 biotech and 5 international pharmaceutical companies.
My goal is to take my experience developing support solutions for sponsors and apply it by working for a sponsor or other company directly, utilizing my end-to-end drug development and regulatory knowledge as well as solution development and management expertise to contribute to the company's mission. I am also interested in & open to roles within the tech/SaaS space, among a variety of others.
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. for a week once a quarter)
Primary expertise and experience: Regulatory affairs including de novo IND and BLA filings, project management, value proposition development, cross-functional & multinational team collaboration and management, stakeholder management, vendor evaluation
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I have collaborated with cross-functional teams and subject matter experts to develop product regulatory development support solutions and value propositions for over 150 biotech and 5 international pharmaceutical companies. My goal is to take my experience supporting sponsors and apply it by working for a sponsor directly, utilizing my end-to-end drug development and regulatory knowledge as well as management expertise to contribute to the company's mission.
While I am open to discussing regarding a variety of roles, my position preferences include regulatory, program and portfolio management, and analogous solution consulting roles.
Willing to relocate: No, but I am open to discussing a reasonable schedule of visiting HQ/my team's office (e.g. for a week once a quarter)
Primary expertise: Regulatory affairs (with a focus on rare and orphan drug development), project management, value proposition development, cross-functional & multinational team collaboration and management, stakeholder management
Résumé/CV: Please email me for a .pdf of my CV
Email: dyhndz [at] gmail [dot] com
LinkedIn: www.linkedin.com/in/dyhndz
Hi, I am a highly motivated biotechnology professional with a diverse experience background including time at a top 10 global pharma company, national government laboratory, rare disease biotech startup, and now international CRO. I have collaborated with cross-functional teams and subject matter experts to develop product development support solutions and value propositions for over 150 biotech and 5 international pharmaceutical companies. My goal is to take my experience supporting sponsors and apply it by working for a sponsor directly, utilizing my end-to-end drug development knowledge and management expertise to contribute to the company's mission.
While I am open to discuss regarding a variety of roles, my position preferences include program and portfolio management as well as analogous solution consulting roles.
Remote: Yes
Willing to relocate: No, but willing to discuss a mutually agreed schedule of traveling to the office (e.g. once a quarter)
Key experience as regulatory lead: IND, CTA, and sNDA filings, responses to FDA and global health authority queries, orphan drug applications, substantial amendments
Résumé/CV: please email for CV
Email: dyhndz [at] gmail [dot] com
Hi, I am a highly motivated and business-minded regulatory affairs professional with diverse experience seeking employment at a biotechnology or pharmaceutical company. I am open to clinical regulatory strategy roles at a variety of company types and therapeutic area focus, including traditional pharma and AI-based biotech startups alike, just to name two differing examples.
My experience is spread across the biotech startup space, top 10 big pharma, government laboratory, and a contract research organization. Most recently, I functioned as regulatory strategy lead at the mid-senior level for a small molecule anti-seizure medication. I would be happy to discuss how my abilities as a regulatory strategy lead and varied experience in the biopharma field could contribute to advancement of your product pipeline, mesh with your current teams and style of regulatory affairs, and add value to your company.