RayzeBio Director of Regulatory Affairs - Clinical/NonClinical
Bristol-Myers Squibb
RayzeBio Director of Regulatory Affairs - Clinical/NonClinical
Job Description
Global Regulatory Lead for a cutting edge RPT program Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions. Authoring of regulatory documents that are required for regulatory interactions. Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers. Maintaining an expert knowledge of the relevant regulatory landscape. Maintaining a relationship with and representing the company to regulators. Lead the preparation, authoring and submission of regulatory filings (e.g., pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications). Lead the preparation for Health Authority Interactions. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Bachelor's degree or higher 7 or more years of hands-on regulatory experience Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu,225-Ac, 161Tb, F18, Y90, etc. Experience with clinical regulatory strategy in prostate cancer Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment. Excellent written and verbal communication skills. Highly organized, with the ability to multi-task and handle pressure well Meticulous with detail and precision Ability to think through a project or task of diverse complexity and execute independently from beginning to end Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing Strong communication and interpersonal skills Should be assertive, proactive, professional, and confident Excellent professional ethics and integrity Flexibility to adapt in a cross-functional and dynamic environment
Key Responsibilities
- Serve as Global Regulatory Lead for a cutting-edge RPT program
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
- Determine timing and nature of global regulatory interactions
- Author regulatory documents required for regulatory interactions
- Stay updated in relevant disease areas and anticipate changes in standard of care as perceived by regulatory authorities and other key customers
- Maintain expert knowledge of the relevant regulatory landscape
- Maintain relationships with and represent the company to regulators
- Lead the preparation, authoring, and submission of regulatory filings including pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual reports, briefing documents, iPSP/PIP, safety reports, and marketing applications
- Lead the preparation for Health Authority Interactions
Required Qualifications
- Bachelor's degree or higher
- or more years of hands-on regulatory experience
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development
- Familiarity with radioisotopes such as 68Ga, 177Lu, 225-Ac, 161Tb, F18, Y90, etc.
- Experience with clinical regulatory strategy in prostate cancer
Skills Required
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment
- Excellent written and verbal communication skills
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous with detail and precision
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
- Strong communication and interpersonal skills
- Assertive, proactive, professional, and confident
- Excellent professional ethics and integrity
- Flexibility to adapt in a cross-functional and dynamic environment
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Remote, UNITED STATES (Remote)
Salary
Estimated Salary Rangemedium confidence
180,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environmentintermediate
- Excellent written and verbal communication skillsintermediate
- Highly organized, with the ability to multi-task and handle pressure wellintermediate
- Meticulous with detail and precisionintermediate
- Ability to think through a project or task of diverse complexity and execute independently from beginning to endintermediate
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencingintermediate
- Strong communication and interpersonal skillsintermediate
- Assertive, proactive, professional, and confidentintermediate
- Excellent professional ethics and integrityintermediate
- Flexibility to adapt in a cross-functional and dynamic environmentintermediate
Required Qualifications
- Bachelor's degree or higher (experience)
- or more years of hands-on regulatory experience (experience)
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development (experience)
- Familiarity with radioisotopes such as 68Ga, 177Lu, 225-Ac, 161Tb, F18, Y90, etc. (experience)
- Experience with clinical regulatory strategy in prostate cancer (experience)
Responsibilities
- Serve as Global Regulatory Lead for a cutting-edge RPT program
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
- Determine timing and nature of global regulatory interactions
- Author regulatory documents required for regulatory interactions
- Stay updated in relevant disease areas and anticipate changes in standard of care as perceived by regulatory authorities and other key customers
- Maintain expert knowledge of the relevant regulatory landscape
- Maintain relationships with and represent the company to regulators
- Lead the preparation, authoring, and submission of regulatory filings including pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual reports, briefing documents, iPSP/PIP, safety reports, and marketing applications
- Lead the preparation for Health Authority Interactions
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for RayzeBio Director of Regulatory Affairs - Clinical/NonClinical @ Bristol-Myers Squibb.
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~2 Minutes
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RayzeBio Director of Regulatory Affairs - Clinical/NonClinical
Bristol-Myers Squibb
RayzeBio Director of Regulatory Affairs - Clinical/NonClinical
Job Description
Global Regulatory Lead for a cutting edge RPT program Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions. Authoring of regulatory documents that are required for regulatory interactions. Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers. Maintaining an expert knowledge of the relevant regulatory landscape. Maintaining a relationship with and representing the company to regulators. Lead the preparation, authoring and submission of regulatory filings (e.g., pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications). Lead the preparation for Health Authority Interactions. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Bachelor's degree or higher 7 or more years of hands-on regulatory experience Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu,225-Ac, 161Tb, F18, Y90, etc. Experience with clinical regulatory strategy in prostate cancer Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment. Excellent written and verbal communication skills. Highly organized, with the ability to multi-task and handle pressure well Meticulous with detail and precision Ability to think through a project or task of diverse complexity and execute independently from beginning to end Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing Strong communication and interpersonal skills Should be assertive, proactive, professional, and confident Excellent professional ethics and integrity Flexibility to adapt in a cross-functional and dynamic environment
Key Responsibilities
- Serve as Global Regulatory Lead for a cutting-edge RPT program
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
- Determine timing and nature of global regulatory interactions
- Author regulatory documents required for regulatory interactions
- Stay updated in relevant disease areas and anticipate changes in standard of care as perceived by regulatory authorities and other key customers
- Maintain expert knowledge of the relevant regulatory landscape
- Maintain relationships with and represent the company to regulators
- Lead the preparation, authoring, and submission of regulatory filings including pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual reports, briefing documents, iPSP/PIP, safety reports, and marketing applications
- Lead the preparation for Health Authority Interactions
Required Qualifications
- Bachelor's degree or higher
- or more years of hands-on regulatory experience
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development
- Familiarity with radioisotopes such as 68Ga, 177Lu, 225-Ac, 161Tb, F18, Y90, etc.
- Experience with clinical regulatory strategy in prostate cancer
Skills Required
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment
- Excellent written and verbal communication skills
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous with detail and precision
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
- Strong communication and interpersonal skills
- Assertive, proactive, professional, and confident
- Excellent professional ethics and integrity
- Flexibility to adapt in a cross-functional and dynamic environment
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Remote, UNITED STATES (Remote)
Salary
Estimated Salary Rangemedium confidence
180,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environmentintermediate
- Excellent written and verbal communication skillsintermediate
- Highly organized, with the ability to multi-task and handle pressure wellintermediate
- Meticulous with detail and precisionintermediate
- Ability to think through a project or task of diverse complexity and execute independently from beginning to endintermediate
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencingintermediate
- Strong communication and interpersonal skillsintermediate
- Assertive, proactive, professional, and confidentintermediate
- Excellent professional ethics and integrityintermediate
- Flexibility to adapt in a cross-functional and dynamic environmentintermediate
Required Qualifications
- Bachelor's degree or higher (experience)
- or more years of hands-on regulatory experience (experience)
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development (experience)
- Familiarity with radioisotopes such as 68Ga, 177Lu, 225-Ac, 161Tb, F18, Y90, etc. (experience)
- Experience with clinical regulatory strategy in prostate cancer (experience)
Responsibilities
- Serve as Global Regulatory Lead for a cutting-edge RPT program
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
- Determine timing and nature of global regulatory interactions
- Author regulatory documents required for regulatory interactions
- Stay updated in relevant disease areas and anticipate changes in standard of care as perceived by regulatory authorities and other key customers
- Maintain expert knowledge of the relevant regulatory landscape
- Maintain relationships with and represent the company to regulators
- Lead the preparation, authoring, and submission of regulatory filings including pre-IND meeting materials, INDs, IND amendments, CTA/IMPD, annual reports, briefing documents, iPSP/PIP, safety reports, and marketing applications
- Lead the preparation for Health Authority Interactions
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for RayzeBio Director of Regulatory Affairs - Clinical/NonClinical @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs