Product Development Director
The Product Development Director will lead a team in the development and execution of strategies for lifecycle management across the existing portfolio. They will be accountable for developing and executing on global regulatory affairs CMC strategies, ensuring effectiveness in a complex matrix environment.
* Manage regulatory submissions for assigned compounds for global marketing applications and post-approval life cycle activities.
* Evaluate change proposals for global regulatory impact and plan global variations and amendments.
* Interpret applicable regulations to ensure CMC compliance.
* Establish CMC content requirements for regulatory submissions and review content for conformance with established requirements.
* Provide solutions to prevent recurrence of issues and communicate professionally and timely manner.
* Interact directly with international Health Authorities and participate in agency meetings.
* Maintain constructive relations with colleagues within the organization and external partners.
Requirements
* Bachelor's degree in a scientific discipline, advanced degree preferred.
* 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead or equivalent industry experience.
* Experience with active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products is required.
* Expertise in developing alternate strategies based on guidance/regulations.
* Liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings.
* Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
This role requires approximately up to 10-30% travel.
Location: Zurich, Switzerland
Benefits
* Fully funded training programs to enhance professional development.
* A comprehensive compensation package that rewards excellence.
* Ongoing career advancement opportunities in a dynamic work environment.
* A healthy work-life balance with flexible working hours.
* Collaborative team culture that fosters growth and innovation.
Key Responsibilities
* Develop and implement global strategies for lifecycle management.
* Lead cross-functional teams to achieve business objectives.
* Drive business growth through strategic planning and execution.
* Build strong relationships with internal stakeholders and external partners.
* Stay up-to-date with current and evolving regulatory CMC requirements.
What We Offer
* Career Advancement Opportunities
* Training Programs
* Comprehensive Compensation Package
* Flexible Working Hours
* Collaborative Work Environment
Industry
* Pharmaceutical Manufacturing
We are seeking an experienced Product Development Director who will drive our success in product development. If you have a passion for driving business growth and are a leader in your field, we encourage you to apply.
Responsibilities include:
* Driving business growth through strategic planning and execution.
* Leading cross-functional teams to achieve business objectives.
* Developing and implementing global strategies for lifecycle management.
* Building strong relationships with internal stakeholders and external partners.
* Staying up-to-date with current and evolving regulatory CMC requirements.
This role is ideal for an individual who is passionate about driving business growth and has excellent leadership skills. If you are looking for a challenging and rewarding role, please apply now.
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