Associate Director Global Regulatory Strategy

Job Brief

We have a vacancy of Associate Director Global Regulatory Strategy in our company, Cardinal Health. This vacancy is based in Los Angeles CA. Please go through the job detail mentioned below.

Position Title: Associate Director Global Regulatory Strategy
Company: Cardinal Health
Work Type: Full Time
City of work: Los Angeles CA
Salary:
URL Expiry: 2022-12-09
Posted on: jobsintelecom.net

Job Detail

Cardinal Health Regulatory Sciences (CHRS) is a consultancy organization that specializes in regulatory affairs related to drug, device, and biologic product development in the pharmaceutical industry. For 45 years, our industry-trained CMC, nonclinical, clinical, and regulatory consultants have provided expertise and guidance that has enabled pharmaceutical, biotechnology, and medical device companies achieve marketing approval of products. Our mission is in part to design and execute regulatory and product development strategies that reduce the risk of failure and increase financial returns on research investments by pharmaceutical companies worldwide. We provide effective scientific and regulatory consulting services throughout the full product lifecycle.  We are growing and looking for talented regulatory affairs experts to help increase our global presence and lead our clients in achieving product development and marketing approval milestones.

The Associate Director, Global Regulatory Strategy will support multiple pharmaceutical companies in developing and implementing regulatory and clinical strategies, overseeing projects, and liaise with Health Authorities, among others.

Accountabilities

• Leadership, development, and execution of strategies for regulatory and clinical areas of development across a broad range of drug, device, biologic, and combination product modalities and therapeutic areas
• Lead internal and external teams and provide strategic insight, recommendations, and business-oriented regulatory opinions, and align teams to each, as applicable
• Project oversight and management, including budgets, timelines, and resources
• Effectively, proactively, and respectfully communicate and engage project teams to achieve goals and milestones
• Oversee, contribute to, and/or prepare (Modules 1, 2, and 5 as applicable) of regulatory submissions including but not limited to INDs, IDEs, IMPDs, CTAs, NDAs, BLAs, 510Ks, PMAs; meeting requests and information packages; expedited program submissions; 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 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 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

• 6+ years (with advanced degree) or 8+ years (with Bachelor’s degree) regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry and/or in a regulatory affairs consulting capacity or a combination thereof

• Bachelor’s degree in related field, or equivalent work experience, preferred

• Advanced degree (DRSc, PhD, MD, PharmD) in a life science-related discipline preferred but not required
• Regulatory Affairs Certification preferred
• Product development and experience in early to late stage as well as post-approval phases
• Experience communicating and interacting directly with major Health Authorities for PIND, IND, EOP2, pre-marketing application, and/or scientific advice meetings
• Experience in marketing application preparation (Modules 1, 2, and 5), submission, and approval process
• Experience leading face-to-face meetings with FDA and/or other Health Authorities a plus but not required
• Solid knowledge of FDA, EMA, and other global regulations and ICH guidelines
• Demonstrated project management skills, including proven ability to effectively manage 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 supervision
• Demonstrated ability to effectively and positively influence stakeholders
• Strong attention to detail and right-the-first-time approach

Location

• Remote, telecommuter

Miami/Ft Lauderdale Metro Area, Atlanta Metro Area, Philadelphia Metro Area, Dallas Metro Area, Houston Metro Area, Richmond Metro Area

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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