Associate Director Regulatory Affairs

Job Title: Associate Director, Regulatory

Department: Regulatory

Reports to: Chief Regulatory Officer

Job Summary

In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability. You will lead the regulatory strategy and initiatives for your assigned programs.

By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide regulatory guidance and oversight and improve internal standards and systems.

Key accountabilities include providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of Opus Genetics products.

Responsibilities and Duties

·       Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic regulatory guidance on development plans

·       Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines

·       Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments

·       Lead the planning and authoring of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, briefing documents, Pediatric Investigation Plans, annual reports) and coordinate responses to Regulatory Agency requests

·       May serve as the liaison between the company and Regulatory Agencies for assigned projects

·       Develop and maintain knowledge of US, EU and ROW regulations as appropriate for the assigned program(s)

·       Help keep cross-functional team members apprised of new regulations, standards, policies and guidance issued by Regulatory Agencies that may impact the company

·       Perform literature searches, prepare reports and assemble documentation to support project teams as required

·       Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

·       Participate in initiatives aimed at improving internal standards and systems

Qualifications and Skills

·       BS or graduate degree in life sciences preferred

·       8 years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development – both big and small company experience is preferred

·       Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME)

·       Strong FDA and EMA experience required

·       Full functional knowledge of regulatory requirements (regulations, directives and guidance/guidelines) pertaining to the development and registration of drug products in multiple ICH regions

·       Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs

·       Ability to set priorities, work independently, deliver results in a timely manner and adapt and react to new information or changing priorities

·       Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences

Location

 Role is currently remote with home offices in Durham North Carolina. East Coast Candidates preferred.

Salary Range: $160,000-185,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.  Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.