DG
Referent in Organisationsentwicklung and Governance supporting compliance and development at Diakonie Mark - Ruhr. Involved in building internal controls and quality frameworks in a social organization.
About the role
- Director, Regulatory Affairs leading global regulatory strategies for neuroscience programs at MapLight Therapeutics. Collaborating with cross-functional teams for clinical-stage products.
Responsibilities
- Lead global regulatory strategy for development-stage neuroscience programs.
- Serve as the regulatory lead on cross-functional teams and be responsible for developing and implementing global regulatory strategies.
- Work with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies.
- Provide advice on regulatory issues and actively collaborate with cross-functional team members.
- Represent MapLight as a point of contact with FDA and provide support for regulatory meetings and briefing document development.
- Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs.
- Lead or oversee the preparation and submission of regulatory documents.
- Monitor changes in the regulatory landscape relevant to neuroscience.
Requirements
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field preferred.
- Minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on clinical-stage products.
- Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred.
- Demonstrated success leading regulatory submissions and interactions with global health authorities.
- Strong understanding of global regulatory frameworks (e.g., FDA, EMA, ICH).
- Proven ability to influence cross-functional teams and drive strategic outcomes.
- Excellent written and verbal communication skills.
- Ability to work independently and thrive in a fast-paced, evolving environment.
Benefits
- annual bonus opportunity
- medical
- dental
- vision
- life and AD&D
- short term and long term disability
- 401(K) plan with match
- stock options
- flexible non-accrual paid time off
- parental leave
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