At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
This role will develop and lead regulatory strategy (registrations, compliance and complaints/vigilance management) to ensure timely drug development and meet company objectives through the execution of sound regulatory strategies/practices and focused interactions with governmental agencies and business partners.
Essential duties and responsibilities include but are not limited to the following:
· Be accountable for leading the development of strategic plans for pipeline assets and implementation.
· Provides leadership on project teams in all areas of regulatory affairs
· Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and milestones are met to support the business needs of the company
· Plan, execute, and lead successful regulatory agency meetings and interactions per regulatory strategy
· Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future applications (e.g., CTA and IND)
· Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
· Serve as regulatory liaison with global health authorities, business partners, and CROs
· Play a key role as a member of the Development Leadership Team
· Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidance’s and takes a leadership role in assessing and communicating the impact of these requirements to the business
Position Requirements and Experience:
· Science degree(PhD, PharmD, MD, MSc) with 8+ years; Bachelor’s Degree with 10+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry at a minimum
· Experienced global regulatory leader with a proven track record
· Experienced in submitting INDs and in managing international regulatory filings
· Experienced in leading interactions with health authorities such as pre IND, EOP2 meetings etc.
· Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products
· Well-developed critical reasoning skills and in risk management assessments
· Experience in immunological therapeutic areas preferred but not essential
· Experience with line management, professional development, and mentorship of direct reports including providing feedback on employee performance and goal setting
· Possess an entrepreneurial spirit and adaptable to a dynamic environment, with strong leadership and interpersonal skills
· Bright, self-motivated, articulate and creative, as well as collaborative and analytical
· Strong technical judgment with attention to detail and proactively manages and identifies potential issues/risks and recommends/implements solutions with key internal and external stakeholders
· Proven ability to collaborate across multiple functions and build effective relationships
· Demonstrated excellence in independent management of complex projects
· Strong written and verbal communication skills and presentation effectiveness
· RAC certification also preferred but not required
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.