Regulatory Affairs Manager in Emerging Markets in Hong Kong

Our client is a leading biopharmaceutical and currently have an opening for a Regulatory Affairs Manager with Emerging Markets experience. It will be a 6 month contract initially based in Cambridge.

This role will be responsible for Regulatory activities for Asia, including for Korea, Hong Kong, China and Singapore.

Job responsibilities:
Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorization applications.
Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Work is performed under minimal direction of a senior Regulatory Affairs professional.
Will liaise with regulatory authorities, affiliates, and/or distributors to ensure scientific information is being disseminated.
Independently manages high profile or critical programs including IND amendments, annual reports, or post-marketing supplements.
Writes responses to questions from the FDA or other regulatory authorities.
Will be accountable for managing the strict timelines associated with submissions and/or variation approval.

What we are looking for:
Excellent organization skills and ability to work on a number of projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are required.
Must have experience within the Emerging markets including Korea, Hong Kong, China and Singapore.
Must have in-depth knowledge of regulatory requirements, including ICH requirements.

For a confidential discussion, please call Líadán on +44(0) 202 7922 7127.

This position, Regulatory Affairs Manager in Emerging Markets in Hong Kong, was posted on June 20, 2011. The job is located in Hong Kong. Since this job has been published, it has been viewed 62 times.