Senior Director, Regulatory Strategy

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November 13

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Advising clients on strategic regulatory considerations for investigational products • Defining regulatory pathways and strategies for optimized product development • Acting as a regulatory strategy leader and Subject Matter Expert (SME) • Working with cross functional teams to chip in to the development of target product profiles • Providing strategic regulatory oversight across programs and portfolios • Providing strategic regulatory oversight of regulatory interactions • Engaging in and supporting the Strategic Regulatory Consulting team and its development and growth • Participating in and implementing thought leadership initiatives that support and showcase Strategic Regulatory Consulting and the broader organization.

🎯 Requirements

• Advanced degree (PhD, PharmD, MD, MS) in a science related field (Chemistry, Cellular or Molecular Biology, Pharmaceutics or Process Engineering) preferred. • At least 10 years of Product Development/Strategic Regulatory Experience in the pharmaceutical industry with a demonstrable record of career advancement and drug development accomplishments • Significant knowledge of, and experience with US regulatory requirements with a proven track record for successful negotiations with Health Authorities. • Wider global regulatory knowledge is an advantage. • Ability to lead multiple projects, co-ordinate with Subject Matter Experts and lead discussions with clients. • Demonstrated understanding of the entire drug development process is required. • Experience as a consultant is strongly preferred. • Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams. • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

🏖️ Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount