Global Regulatory & Site Start-Up Specialist
Precision for Medicine
An application made for this job — a tailored resume and cover letter that speak straight to the posting.
Job summary
Precision for Medicine is seeking a Regulatory and Start Up Specialist to drive site activation planning and regulatory submissions for clinical trials. You will prepare CTAs, compile dossiers, interact with authorities, and maintain trackers while coordinating with cross-functional teams to ensure timely startup across assigned sites and countries.
The ideal candidate has 1+ year of startup/regulatory experience in CRO or pharma, strong communication skills, and fluency in English.
Qualifications
- Bachelor’s degree in life sciences or related field (ideally scientific/healthcare).
- 1+ year as Regulatory or Start-Up specialist (or similar) in CRO/pharma.
- Fluency in English.
- Experience with CA/EC submissions and regulatory interactions.
Responsibilities
- Prepare CTAs and submission dossiers for regulatory authorities per local requirements.
- Interface with CA/EC and respond to submissions.
- Maintain regulatory trackers and project plans; update regulatory leadership.
- Coordinate start-up plans, site activation documentation, and essential documents.
- Assist with budget negotiations and site contracts as needed.
Skills
Education
Tools
Job description
Precision for Medicine is seeking a Regulatory and Start Up Specialist to drive site activation planning and regulatory submissions for clinical trials. You will prepare CTAs, compile dossiers, interact with authorities, and maintain trackers while coordinating with cross-functional teams to ensure timely startup across assigned sites and countries.
The ideal candidate has 1+ year of startup/regulatory experience in CRO or pharma, strong communication skills, and fluency in English.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
