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Snr Manager, Regulatory Affairs APAC (TEMPORARY)

Location Wanchai, Hong Kong SAR
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

SUMMARY We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for overseeing the strategy, preparation and submission of marketing applications (MAs) and other submissions to regulatory authorities in Asia Pacific (APAC), including Japan and Australia.  This is a 12-18month contract role for maturity leave cover. 

RESPONSIBILITIES

Develop regional regulatory strategy and feasibility of market entry for BioMarin products (biologics, pharmaceuticals, orphan diseases), identify risks and potential gating factors for approval.
Evaluate local regulations/guidances, and regional/governmental changes for impact to any complex submission (e.g., MA) and commercial plans. 

Oversee the planning and preparation of complex submissions such as marketing applications (MAs), Orphan Drug designation applications (ODDs), Priority Review requests, labeling and clinical/nonclinical supplements in key markets in APAC including Japan and Australia.

REQUIREMENTS

8 years of experience in the biotechnology or in the pharmaceutical industry with 5 years of experience in Regulatory Affairs , including demonstrated knowledge and understanding of the Regulatory environment in the APAC region.

Proven track record for preparing, submitting, and gaining approvals for Marketing Applications and post-marketing variations, particularly for biologics and/or orphan disease products.

Proven ability to independently manage critical projects as part of a interdisciplinary team.

BA/BS degree, life sciences preferred.



Liaise with regional regulatory personnel, consultants/contractors, partners and other regulatory counterparts as needed

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Wanchai

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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