|Regulatory Clinical Trial – Senior Associate
To conduct and manage compliant clinical trial application submission as required and ensuring compliance with local and international regulations governing clinical trials.
Duties and responsibilities
- Analyze regulatory requirements and prepare comprehensive document packages for clinical studies (Phase I-IV) including regulatory and Ethics Committee (EC).
- Liaise with in-country/local person for clinical trial registration
- Act as the point of contact between sponsors and investigating sites
- Prepare and maintain clinical trial dossiers in accordance with applicable regulatory requirements of respective regulatory agencies, ECs and Institutional Review Boards (IRBs)
- Collaborate with sponsors, sites, and stakeholders to compile submission dossier and deliver agreed project scope in compliance with sponsor requirements
- Coordinate with sponsor/CRO to monitor and track clinical trial milestones, submissions and approval timelines to ensure submission packages are in accordance with timelines
- Provide oversight on CRO/sponsor activities including regulatory and study start up processes
- Compile submission dossiers in eCTD or xml format
- Communicate the impact of regulatory changes and key regulatory information to stakeholders, providing guidance and implementing necessary processes.
- Ensure clinical research compliance with regulatory agency requirements
- Train/mentor team members to ensure compliance with ICH GCP regulations
- Facilitate cross-functional collaboration with teams to collect and compile dossiers/packages for clinical trials applications (Regulatory Affairs, Medical Writing, Pharmacovigilance, Regulatory Strategy, etc).
- Develop country-specific clinical trial submission strategies
- Support in drafting various clinical documents for submission including cover letters, table of content, clinical trial application forms & heath authority responses
- Compile documents for CTA amendments, End of Study notifications, IB notifications, Protocol amendments, ICF amendments etc
- Analyze and suggest feasible submission strategies to Global Regulatory Strategy team
- Monitor inquiries received from regulatory agencies, ECs, and IRBs, analyze patterns in submissions, and identify potential risks that could affect clinical trial implementation, regulatory submissions, and initiation of study activities contributing to Regulatory Intelligence
Education & Experience
- Bachelor’s or Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge of clinical trial applications, protocols, investigator’s brochures, etc
- Experience in developing and compiling clinical trial application packages
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
1-4 to start with.
Gurgaon, Haryana (INDIA)