Manager Regulatory Affairs-某全球知名制药有限公司

Responsibilities:

1 Deliver innovative and beneficial consumer drug products regulatorystrategy in a timely manner.

2Strategic leadership of consumer drug product development andNPD/MPR registration projects to meet the business objectives for the business.

3Straight to point communication with stakeholders, such as: Plant,Regional, HQ, MKT, R&D, Med, Toxicity, Clinical Operation, GCMC etc.

4 Full compliance with all government regulations and corporatepolicies including oversight of corrective actions.

5Coordination and implementation of consistent standards andprocesses, as well as sharing of best practices across the PCH regulatoryorganization.

6 Direct the growth and professional development of the RA teammembers.

7Manage the regulatory professionals ensuring high qualitydeliverables against their objectives

8 Accountability for capacity and capability management.

9Development of working/partnering relationships with key agencies inthe business.

10Timely submission of regulatory applications for new productregistrations.

11Be a recognized as a key partner for local business activities andinitiatives, including licensing opportunity considerations, innovativeregulatory strategies, and talent management.

 

Technical Skill Requirements

1Good technology of CMC, preclinical, clinical.

2Understanding of regulatory agency philosophies and guidelines.Capture regulatory trend to reflect into regulatory strategy change. Experiencepreparing and submitting health product registration applications, variationsand renewals.  Working with andinfluencing, opinion leaders, external organizations and facilitating approvalof innovational projects.

3Communicates effectively using a variety of mediums appropriate tothe setting

4Can negotiate skillfully in tough situations with both internal andexternal groups. Can be direct and forceful as well as diplomatic. Gains trustquickly of other parties to the negotiations

5Effectively identifies issues and challenges and works with partnergroups to identify options and implement agreed solutions

6Understands how role is impacted by and contributes to externalbusiness environment and financial drivers

7Makes decisions in a timely manner, sometimes with incompleteinformation and under tight deadlines and pressure; able to make a quickdecision.

8Makes good decisions based upon a mixture of analysis, wisdom,experience, and judgment; most of his/her solutions and suggestions turn out tobe correct and accurate when judged over time; sought out by others for adviceand solutions. 9Will stand upand be counted; doesn't shirk personal responsibility; can be counted on whentimes are tough; willing to be the only champion for an idea or position; iscomfortable working alone on a tough assignment.

10Can be counted on to exceed goals successfully; is constantly andconsistently one of the top performers; very bottom-line oriented; steadfastlypushes self and others for results.

Qualifications (i.e., preferred education,experience, attributes)

11Tertiary qualifications in pharmacy or a science degree

126+ years Regulatory Affairs experience gained with multinationalpharmaceutical working with consumer health products.

13 Regulatory Experience with either as healthcare industry isrequired.

14Excellent English skills for accurate and effective communication.

15Proven ability to manage regulatory issues and is solutionsorientated.

16Proven ability to consistently deliver to time, cost and qualitystandards.

17General management experience with line management anddemonstrates leadership in driving for success is desirable

18Demonstrable experience of effective delivery of objectives in acomplex matrix environment.