Associate Director, Regulatory Affairs and Submissions

at  Altasciences

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.
About The Role
The Associate Director, Regulatory Affairs and Submissions, is responsible for providing regulatory guidance to Sponsors related to drug development and submission requirements, leading the initiation (requests), preparation (meeting packages), and conduct of a variety of Agency interactions (Type A – C, INTERACT meetings), leading regulatory submission preparation (including assessing for gaps in requirements) and filing activities, may act as a project resource for junior staff/peers to ensure workload is managed, strategies are aligned, and submissions are of the highest quality.

What You’ll Do Here

• Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide regulatory guidance related to drug development and submission preparation
• Interact with sponsors as a regulatory consultant to build trust and encourage engagement
• Evaluate, develop, plan and prepare regulatory submissions (INDs primarily) for new drugs under development with the collaboration of multiple cross-functional teams
• Provide critical review of key Health Authority submissions such as pre-IND, IND, meeting requests, briefing documents and response documents
• Perform gap analysis for drug development programs and to inform regulatory strategies
• Interpret laws and regulations (FDA, Health Canada, ICH, EMA, and MHRA)
• Lead, manage and prepare clinical trial submissions
• Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies
• Communicate, consult and negotiate with health authorities
• Respond in a timely manner to health authority requests
• Resolve issues in a timely manner
• Participate to sponsor’s audits and regulatory inspections
• Provide regulatory input into client-provided proposals
• Maintain a positive, result orientated work environment, build partnerships with cross-functional teams/departments, maintain a positive team-based culture
• Support business development for proposals and costing; support bid defense meetings
• Participate in the development of standard operating procedures (SOPs)
• Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines
• Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines
• Participate in departmental or interdepartmental quality improvement initiatives
• Train and mentor other team members
• Maintain and participate in the objectives of the department

What You need to Succeed

• MSc/MS, PhD in a relevant field; 5+ years of predominantly US regulatory experience in an industry setting
• Strong knowledge of drug development and regulatory policy including ICH, FDA, and Health Canada guidelines related to early phase drug development
• Demonstrated experience with leading IND submissions in US, experience with other regulatory agencies an asset
• Ability to assess nonclinical data for gaps in an IND-enabling package
• Leadership skills
• Excellent verbal and written communication skills
• Critical thinking skills and ability to acquire and apply knowledge quickly
• Professional attitude and strong interpersonal skills
• Ability to work well with a multi-disciplinary team of professionals
• Client-focused approach to work
• Flexible attitude with respect to work assignments and new learning
• Ability to prioritize workload
• Thorough understanding of clinical research, drug development process and applicable regulatory guidance
• Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems
• Experience with Health Canada is an asset. Willingness to learn is required.

What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Reviews

• Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide regulatory guidance related to drug development and submission preparation
• Interact with sponsors as a regulatory consultant to build trust and encourage engagement
• Evaluate, develop, plan and prepare regulatory submissions (INDs primarily) for new drugs under development with the collaboration of multiple cross-functional teams
• Provide critical review of key Health Authority submissions such as pre-IND, IND, meeting requests, briefing documents and response documents
• Perform gap analysis for drug development programs and to inform regulatory strategies
• Interpret laws and regulations (FDA, Health Canada, ICH, EMA, and MHRA)
• Lead, manage and prepare clinical trial submissions
• Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies
• Communicate, consult and negotiate with health authorities
• Respond in a timely manner to health authority requests
• Resolve issues in a timely manner
• Participate to sponsor’s audits and regulatory inspections
• Provide regulatory input into client-provided proposals
• Maintain a positive, result orientated work environment, build partnerships with cross-functional teams/departments, maintain a positive team-based culture
• Support business development for proposals and costing; support bid defense meetings
• Participate in the development of standard operating procedures (SOPs)
• Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines
• Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines
• Participate in departmental or interdepartmental quality improvement initiatives
• Train and mentor other team members
• Maintain and participate in the objectives of the departmen