MANAGER, REGULATORY AFFAIRS CMC
Descrição da oferta de emprego
is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements.
Master’s degree in Regulatory Affairs or related field plus 2 years of related experience.
Prior experience must include.
Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions; Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments.
Up to 20% remote work allowed.
Apply on-line at www.
akedajobs.
om and search for Req #R.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Detalhes da oferta
- Indeterminado
- Em todo o Brasil
- Indeterminado - Indeterminado
- Indeterminado
- 28/03/2024
- 26/06/2024
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