Toxicology Lead

About the Role:

We are seeking a highly skilled Toxicology Lead to join our team at Bayer. As a key member of our Consumer Health division, you will be responsible for providing critical review and toxicology risk assessment reports in support of assigned projects.

Key Responsibilities:

• Participate in multi-functional New Product Development (NPD) teams as a Toxicology representative to guide safety strategy for supporting new products and technologies.
• Contribute to the design and execution of preclinical toxicology studies to support clinical trials and product registration for BCH's global market.
• Produce documents for Health Authorities for non-clinical purposes, e.g. CTD nonclinical modules and justification documents, with minimal guidance and supervision.
• Generate biocompatibility risk assessments for medical device products according to ISO (International Organization for Standardization) guidance.
• Compile European Cosmetic Product Safety Reports (CPSR) following the appropriate regulation.
• With guidance from PVRM management, conduct evaluation on safety, toxicology, pharmacology and pharmacokinetics on external licensing candidates and Rx-to-OTC switches.
• Identify global product safety/regulatory trends, communicate their potential impact on New Product Development as well as BCH's existing portfolio to leadership teams and develop/implement appropriate corporate responses as necessary.

Requirements:

• Doctoral degree (e.g. Ph.D.) in Toxicology, Pharmacology, or a closely related field, and solid relevant industry experience or overall equivalent experience profile.
• In-depth knowledge of regulations and guidance's administered by FDA, EMA, ISO, and European Commission on medicinal, medical device, and cosmetic products.
• Expertise in toxicology and risk assessment.
• Certified toxicologist (e.g. Diplomate of American Board of Toxicology) is preferred but not required.
• Experience in the OTC drug industry, medical device, and/or cosmetic industry is preferred.
• Ability to work under pressure in an environment of constantly changing priorities.
• Ability to work well in a team environment but contribute.

About Bayer:

Bayer is a global life science company with a rich history of innovation and commitment to making a positive impact on people's lives. We are dedicated to advancing health and nutrition for a better world, and we are seeking talented individuals like you to join our team.

What We Offer:

• Competitive salary and performance bonus.
• 28 days annual leave plus bank holidays.
• Private Healthcare, generous pension scheme and Life Insurance.
• Employee discount scheme.
• State of the art offices.
• International career possibilities.
• Flexible and remote working.
• Help with home office equipment.

Equal Opportunities:

Bayer is an equal opportunities employer and welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination.

Location:

United Kingdom : Berkshire : Reading

Division:

Consumer Health

Reference Code:

818063

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