【Alexion Japan】Associate Director, Regulatory

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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.