Experience:
3-5 years of experience
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Employment Type:
Full time
Posted:
8/24/2017
Job Category:
Business Development
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Regulatory Affairs & PV Specialist Job
MSD | Moody A F B, Georgia
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Job Description

Regulatory Affairs & PV Specialist-REG003135

Description

- The Regulatory Affairs & Pharmacovigilance Specialist is responsible for ensuring regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.

- Serves as company Pharmacist, Country Regulatory Affairs (CORA) person and Pharmacovigilance Designated Point of Contact DPOC.

- Holds and maintains his/her Poison type A license and makes it available for the use of MSD Animal Health Malaysia ensuring compliance with all necessary regulations attached to it.

- Provides subject matter vigilance to drive compliance with relevant regulations.

- Ensures regulatory support through product life cycle including labelling and dossier modifications.

- Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes.

- s supplemental applications and participates in negotiations during regulatory approval processes for applications with the regulatory agencies.

- Participates in inter-company organizations focusing on specific industry-related issues.

- Stays current on all regulatory, market, and industry developments.

- Ensures current knowledge of domestic and some international regulatory requirements.

- Builds long term effective relationships and keeps open communication with MSD Animal Health Regional / Global colleagues and all the MSD subsidiaries to support trans-national cooperation success.

- Monitors regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies.

- Cooperates with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others.

- Contributes with regulatory support during health authority site inspections.

- Attends inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes.

- Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements.

- Takes participation in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations.

- Serves as Designated Point of Contact (DPOC) for Pharmacovigilance related issues in Malaysia & Singapore

Qualifications

- Bachelor's degree in Pharmacy

- PRP certified, holder or able to obtain a Poison Type A License.

- At least 3 years of pharmaceutical, biological, or pesticide regulatory experience, preferably in the veterinary industry.

Job: Regulatory Affairs Generic Job Title:Sr. Spclst, Regulatory Affairs

Primary Location: APAC-MY-B-Petaling Jaya

Employee Status: Regular

Number of Openings: 1

Company Trade Name:MSD

About MSD

MSD Ignition is a company built on Customer Satisfaction and Service. That is why all of our products go through regimented test procedures before they are ever packaged and shipped. MSD stands behind our products for one full year after purchase and we have an excellent repair department. Terms of Warranty and Service are as follows: Limited Warranty Autotronic Controls Corporation warrants MSD Ignition products to be free from defects in material and workmanship under normal use and if properly installed for a period of one year from date of purchase. If found to be defective as mentioned above, it will be replaced or repaired if returned prepaid along with proof of date of purchase. This shall constitute the sole remedy of the purchaser and the sole liability of Autotronic Controls Corporation to the extent permitted by law, the foregoing is exclusive and in lieu of all other warranties or representations whether expressed or implied, including any implied warranty of merchantability or fitness. In no event shall Autotronic Controls Corporation be liable for special or consequential damages. This warranty is only valid on products purchased from MSD Authorized Dealers.

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