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Altasciences · 1 hour ago

Senior Director, Regulatory Affairs

Overland Park, KS

Full-time

Onsite

Director/Executive

$150K/yr - $200K/yr

10+ years exp

Altasciences is a company dedicated to assisting in the discovery, development, and manufacturing of new drug therapies. The Senior Director, Regulatory Affairs will oversee regulatory strategy, execution, and compliance across all phases of drug development, focusing on early-stage molecules while leading a team and liaising with global health authorities.

BiotechnologyHealth CareMedical

Responsibilities

Partner with business development to identify and hold initial conversations with potential clients (focusing on clients at the end of the discovery phase)

Consult with client pre-award to determine regulatory requirements to meet program needs

Define and prepare regulatory strategy plans

Create, present, and defend content for proposals

Build, mentor, and manage a high-performing regulatory team

Serve as a point of contact for regulatory questions and oversee interactions with regulatory agencies, ensuring effective communication and constructive working relationships with regulatory authority representatives

Partner with Clinical, CDMO, Nonclinical, Medical Writing, and Project Management teams to ensure integrated regulatory planning and execution

Lead the preparation for regulatory meetings (pre-Investigational New Drug Application [IND], pre-Clinical Trial Application [CTA])

Oversee regulatory submission requirements and provide content for regulatory submissions

Implement SOPs and best practices to enhance efficiency and compliance

Monitor the development of new regulatory requirements or guidance documents and advise on the impact on the business or development programs

Identify overall risks to regulatory plans in conjunction with project teams and participate in mitigation strategy team

Qualification

Regulatory strategyFDA submissionsHealth Canada submissionsGMP knowledgeGLP knowledgeGCP knowledgeRisk assessmentTeam leadershipInterpersonal skillsCommunication skills

Required

10 years' experience in regulatory affairs in a CRO, biotechnology or pharmaceutical setting

Demonstrated success in leading early-stage regulatory strategy and submissions in North America (FDA and Health Canada) for a variety of indications and molecules

Deep knowledge of Health Canada and FDA regulatory frameworks, including CTA and IND processes

Excellent scientific and business judgment

Proven track record practicing sound judgment as it relates to risk assessment

Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)

Understanding of where to seek and how to interpret regulatory information

Excellent verbal and written communication skills

Professional attitude and strong interpersonal skills

Ability to work well with a multi-disciplinary team of professionals