Director, Global Regulatory Affairs

in Remote Location

Director, Global Regulatory Affairs Job

Job Description Job Attributes+

  • Job ID

    cf0a7fc2-35c1-4fb9-83b7-5ac4087bf014

  • Req #

    20087929

  • Job Location

    Remote Location

  • Job Category

    Regulatory

  • Job Type

    Regular

  • Schedule

    Full time

The Director, Global Regulatory Affairs will support multiple pharmaceutical companies as a Regulatory Affairs Leader and Subject Matter Expert. Key contributions of this role include developing and implementing regulatory strategies, overseeing all aspects of programs and projects, and lead Health Authority meetings and interactions for our clients, among others.

Accountabilities

Leadership, development, and execution of global regulatory strategies across a broad range of drug, device, biologic, and combination product modalities and therapeutic areas

Lead cross-functional internal and external teams, including executive level client teams, and provide strategic insight, recommendations, and business-oriented regulatory opinions, and align teams to each, as applicable

Program and project oversight and management, including budgets, timelines, and resources

Effectively, proactively, and respectfully communicate and engage program and project teams to achieve goals and milestones

Oversee, contribute to, and/or prepare all or part of regulatory submissions including but not limited to INDs, IDEs, IMPDs, CTAs, NDAs, BLAs, 510Ks, PMAs, meeting packages, and those for expedited programs, and ensure they meet regulatory requirements, industry standards, and timelines

Perform and prepare due diligence assessments that may include risk mitigation strategies  

Prepare teams for and lead meetings, including face-to-face, with Health Authorities

Serve as the Health Authority point of contact, including as US Agent for ex-US clients

Build, manage, and maintain successful partnerships with clients

Mentor and share knowledge with other CHRS Consultants as needed to help build, establish, and maintain a global regulatory consulting presence

Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance

Contribute to business development activities, including initial client meetings, and provide input on proposals and contracts

Review and approve weekly internal timecards and monthly project invoices

Continually demonstrate Cardinal Health Values and Leadership Essentials

Qualifications

10+ years (with advanced degree preferred) or 15+ years (with Bachelor’s degree in a life sciences discipline preferred) regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry and/or in a regulatory affairs consulting capacity or a combination thereof

Advanced degree (DRSc, PhD, PharmD) preferred but not required;

Regulatory Affairs Certification preferred, but not required

Experience communicating and interacting directly with major Health Authorities for PIND, IND, EOP2, pre-marketing application, and/or scientific advice meetings in more than 1 major region

Experience with and oversight of marketing application preparation, submission, and approval process in more than 1 major region

Demonstrated experience leading face-to-face meetings with FDA and/or other Health Authorities

Solid knowledge of FDA, EMA, and other global regulations and ICH guidelines

Expert in product development and experience in early to late stage as well as post-approval phases

Demonstrated leadership and program/project management skills, including proven ability to effectively manage cross-functional teams

Regulatory affairs experience in advanced or gene therapies and/or devices a plus but not required

Experience working in a matrixed, global, and multi-site environment

Strong written and verbal, analytical, organizational, and interpersonal skills

Ability to manage multiple ongoing projects, each at various stages of development, with minimal if any supervision

Demonstrated ability to effectively and positively influence stakeholders

Strong attention to detail and right-the-first-time approach

This is a remote work from home position

Anticipated salary range: $180,000-$200,000

Bonus eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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