We are seeking a Senior Manager, Corporate Regulatory Affairs to oversee and harmonize regulatory affairs processes across multiple sites, ensuring compliance with international regulations. This role is ideal for an individual with expertise in Regulatory Affairs (RA) and CMC development, experience in working with regulatory authorities and customers, and strong English language skills.
Responsibilities:
* Develop and implement a standardized RA framework across all sites.
* Ensure regulatory compliance for products, taking into account specific customer requirements.
* Advise local RA and CMC teams on developing regulatory strategies for new projects, collaborating with internal and external partners.
* Support the preparation, submission, and maintenance of regulatory documents.
* Provide hands-on support for applying corporate RA standards at various locations.
* Coordinate regulatory activities during CMC process development and provide consultation to project teams.
* Lead the corporate RAC organization within the Quality division.
* Maintain consistent regulatory standards and manage the e-CTD submission system.
Requirements:
* PhD in Chemistry, Pharmacy, or a related field, with good understanding of GMP guidelines.
* Strong expertise in RA and CMC development, with knowledge of drug substances and products.
* Minimum 5 years of experience in a RA role, with 5 years of leadership or consulting experience in a regulated environment.
* Proven experience working with regulatory authorities and customers.
* Excellent communication skills and ability to work effectively in multicultural settings.
* Strong English language skills, flexible work attitude, and decision-making abilities.
This is an exciting opportunity to contribute to the success of a dynamic and fast-growing company at the forefront of life sciences.