This is what you will do:
Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical tasks required for product development in a timely and appropriate manner.Describe the job in a few sentences. Bullet point responsibilities should fall in the next section
You will be responsible for:
Lead the interaction and communication with the local HAs and Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.
Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.
• Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
• Manages pharmaceutical regulatory affairs schedules for product development plan.
• Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.
• Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.
• Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.
• Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed with Regulatory-Ope.
Lead the Submission sub-team as a Japan Regulatory Lead of Japan Project Team and join the Global Regulatory Affairs sub team
Main point of contact for relevant local HA inspections and support for interactions with relevant departments/functions for response(s) to local HAs
Local Management of, or support for incidents involving regulatory matters
Support Director's job
You will need to have:
• Minimum 5-10 years work experience in RA including more than 3 products approval experience as JRA leader
We would prefer for you to have:
• BA/BS degree (or equivalent) in life sciences (medical, pharmacy, veterinary medicine, science, engineering, agriculture, medical economics etc). MS preferred.
Date Posted
17-5月-2024Closing Date
29-9月-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
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