The (Associate) Director, GRA will be responsible for some activities for assigned projects related to the development and implementation of regulatory strategy and management of regulatory submissions.

The (Associate) Director, GRA in close collaboration with the Head of the GRA, will develop and advance organizational policies and procedures. Working in a team environment, the (Associate) Director, RA will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration, and post marketing requirements (PMRs). The (Associate) Director will be effective in collaborating within the organization and provide regulatory leadership by communicating, executing, and providing guidance to team members toward achieving the department/corporate objectives.

Responsibilities:

In close collaboration with the Head of GRA develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans Coordinates, supports and ensures alignment in regard to Partner submissions to ensure clear status of the activities and adherence to the agreed schedule. Ensures timely escalation of issues and concerns with impact assessment and risk mitigation plans as required. In close cross-functional collaboration prepares INDs, CTAs, amendments, briefing documents, and marketing applications (NDAs, MAAs) as needed; Demonstrates a solid understanding of current US regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas when applicable. Able to anticipate risks and proactively develops solutions to identified risks; understands probabilities of technical success for the solutions; Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide the team in building an appropriate regulatory strategy; Demonstrates understanding of broad concepts within Regulatory Affairs and implications across the organization and globally; Represents company at regulatory agencies for assigned products, including planning and conducting meetings, as well as ensuring submitted documents are compliant and of the highest quality; Works with cross-functional teams and GRA team members to ensure adherence to timelines for regulatory submissions. Regularly reports to line management on progress against objectives and plans. Directs project execution against plan and provides technical support, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team. Support and participate in the development of GRA systems and processes Ensure line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner; Other regulatory affairs duties as assigned or as business needs require. Duties, responsibilities, and activities may change, or new ones may be assigned as business and organizational requirements evolve. Reporting structure of this role is detailed in the company's official organizational charts.

Requirements / Qualifications:

Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences. Advanced degree preferred, but not required. At least 6+ years of Regulatory Affairs experience in small molecule or biologic drug development and registration activities or a combination of 4+ years of Global Regulatory Affairs and related experience. Candidates must have proven strategic development capabilities related to new drug development and commercial support activities. Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and internationally. Rare disease and pediatric drug development experience is highly desirable. Must have strong communication and interpersonal skills needed to influence internal stakeholders in a diplomatic manner to ensure project success. Demonstrate excellent teamwork and communication skills with the ability to impact and influence the decisions of a team. Good oral and written communication, time management, and team-oriented leadership skills are essential. Excellent computer and project management skills are essential for the successful candidate.