Experience:
No experience
Employment Type:
Full time
Posted:
8/24/2017
Job Category:
Engineering
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Regulatory Affairs Lead- Animal Health Job
MSD | Pell City, Alabama
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Job Description

Regulatory Affairs Lead- Animal Health-REG003132

Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, sound technical knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


THE OPPORTUNITY

Our Animal Health commercial regulatory team based at our Upper Hutt site has an exciting opportunity for a Regulatory Affairs Lead (RAL) on a 12 month fixed term contract. As a RAL, you will be responsible for providing critical strategic and operational leadership on new product and innovation development and registration projects. Responsibility will focus on providing regulatory and technical support to project teams to drive results and ensure compliance with appropriate legislation, company policies and local procedures.

Some key responsibilities will include:

- Provide strategic and operational leadership for new product and innovation development and existing product registrations. Advise regulatory requirements and actively contribute to and drive implementation of regulatory strategies.
- Provide interpretation of key New Zealand product registration and other applicable local and international regulations to MSD Animal Health (MSDAH) Regulatory Affairs, R&D and Marketing/Technical teams.
- Responsible for filing of regulatory applications and contribute and/or lead submission activities. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
- Effectively plan, organize, and conduct in close collaboration with leads from other functional areas. Assure compliance with project team timelines and milestones.
- Drive adoption of best practices across the regulatory team and other internal stakeholders to optimise business processes, growth opportunities and drive results.
- Manage and grow effective stakeholder relationships between MSDAH NZ and New Zealand Regulatory authorities such as ACVM, EPA, Biosecurity and Industry groups.
- Provide advice and assistance to projects to ensure compliance with local ACVM and HSNO legislation, company policies and local procedures to support the business objectives and project milestones.
- Assist in development and monitoring of Pharmacovigilance procedures to ensure New Zealand MSDAH PV activities in alignment with Global PV and local authority requirements.

Qualifications

ABOUT YOU

This is a varied, fast-paced and challenging role which will require someone who works best in an agile environment, with the ability to work under pressure and excellent project management skills to meet deadlines.

Some key requirements of this opportunity include:

- Tertiary or Post-Graduate Degree in biological/pharmaceutical/veterinary science.
- Experience working within a regulatory pharmaceutical industry environment advantageous.
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrates highly advanced written communication skills in report writing and document review.
- Balance strategic thinking and strong analytical and problem solving skills with ability to execute. Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approva.
- A strong self starter with well developed skills in negotiating, influencing and project management.
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.

MSD ANIMAL HEALTH

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals through science. We offer veterinarians, farmers, pet owners and governments the widest range of veterinary pharmaceuticals, parasiticides, vaccines and health management solutions.

MSD is an equal opportunity employer - proudly embracing diversity in all of its manifestations.


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

Primary Location: APAC-NZ-WGN-Hutt City

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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