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Principal Consultant - Regulatory Affairs Generalist

Parexel International Corporation

USA - Any Region - Home Based

Parexel’s Regulatory Consulting Services (RCS) team is comprised of smart, passionate, and dedicated experts who are driven by the extremely important work they do to assist our clients in delivering new and innovative medical treatments for patients. This talented team is growing, and we are seeking a Principal Regulatory Affairs Generalist us. If you are self-directed with excellent communication and influencing skills, and thrive in a fast-paced, dynamic environment where you will continue to learn and have a direct impact through your work, we would love to connect!

A Principal Regulatory Affairs Generalist will be a talented, seasoned, and motivated regulatory affairs leader with prior experience creating and executing global regulatory strategies aimed at the most efficient regulatory pathway for medical therapies. You will have solid knowledge of US FDA regulatory requirements and procedures and have substantial experience in preparing and/or managing major regulatory submissions to FDA. You will also have strong knowledge of and demonstrated experience in FDA’s Pediatric Programs, Orphan Drug, and expedited development programs. As a Principal Regulatory Affairs Generalist, you will work with clients and internal cross-functional project teams in planning product development strategies and leading global regulatory submissions within the Clients’ portfolios. You will be well versed in regulatory requirements and will share your knowledge and regulatory advice with clients on key aspects of drug development.

As a Principal Regulatory Affairs Generalist, you will: Liaise with clinical, nonclinical, CMC, and Client’s team members to develop and execute regulatory strategies aligned with Client’s business objectives. Provide guidance, direction, and leadership on those strategies to development teams and executive management Lead teams in producing complex, global regulatory submissions to include review and approval of regulatory documents in support of filings including INDs, briefing materials for Health Authority (HA) meetings, pediatric plans, orphan drug applications, NDAs/BLAs, etc. Lead teams to plan for critical HA meetings (e.g., Pre-IND, EOP2, pre-NDA/BLA); prepare for HA meetings including determining meeting objectives, key messages, and represent Clients with HAs including negotiations on complex issues related to early development Manage complex projects from inception to completion to include providing regulatory guidance to help establish team goals, determining objectives, anticipating needs, initiating complex work, and leading others to drive complex, critical regulatory submissions to completion which align with Clients’ goals Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends Demonstrate excellent communication skills to present complex regulatory information Ensure Clients are informed of any relevant changes in the regulatory landscape and Client’s regulatory strategies and product development activities are optimized. When necessary, draw upon your therapeutic and/or product expertise to propose effective and practical solutions Thought Leadership Delivers presentations at seminars and industry group meetings Authors articles for publication in industry magazines, newsletters, book chapters and other forums May serve as a member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise Drives knowledge-centered activities within Parexel Consulting as well as contributes to Parexel business process improvements Contribute to new RCS service and consulting model development QualificationsBusiness Development Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management Presents information about Parexel Consulting service offerings reflecting the organization’s capability to support client needs Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship Leverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clients Participates in project scoping calls and proposal preparation Delivers sales presentations and participates in bid defense meetings when needed Actively participates in account planning for key clients

Other Parexel responsibilities Meets established metrics as specified in scorecard on an annual basis Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management Defines self-development activities to keep current within the industry (i.e., maintain membership in a relevant industry and/or scientific/technical association) Participates in thought leadership activities (i.e., present speeches or seminars to industry groups and/or author articles.)


• High-level consulting skills

• Critical thinking and problem-solving skills

• Project leadership and management knowledge

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Client-focused approach to work

• Results orientation

• Teamwork and collaboration skills

• Proficiency in local language and extensive working knowledge of the English language

• Account planning and support

• Networking

• Business acumen and analysis

• Self-confidence and control

Knowledge and Experience 10-15+ years of experience with expert level industry or regulatory knowledge; experience with a regulatory agency (such as FDA, MHRA) is a plus Education Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree preferred The ability to travel up to 30% domestically and/or internationally may be required

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

2022-05-21 00:05:23

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