KalamazooRecruiter Since 2001
the smart solution for Kalamazoo jobs

Manager/ Assoc Director Regulatory Affairs CMC

Company: Zoetis, Inc.
Location: Kalamazoo
Posted on: September 9, 2019

Job Description:


The successful candidate will support all regulatory CMC aspects of an assigned product portfolio associated with Zoetis business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance. Develop regulatory CMC filing strategies for global pharmaceutical dosage forms. Support CMC activities for new product development teams and post-approval manufacturing changes or site transfers. Prepare responses to global Health Authority queries including FDA/CVM. Maintain knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations and assist in the development of Zoetis regulatory positions and strategies.

Develop strong working relationships with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio. Provide regulatory support and serve as a technical liaision on Development teams in their efforts to deliver a quaility CMC technical section that will meet global requirements for registration, approval and launch of a new product. Develop a knowledge of CMC regulatory science. Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices.


Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable

Position may require some travel less than 10%


Minimum of a Bachelor degree/ Master degree with six years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical or pharmaceutical products. Strong technical background and excellent communications skills required with regulatory experience highly preferred. Candidate will review/author regulatory assessments for CMC activities and contribute to development and execution of submissions for post approval CMC manufacturing compliance. Must have the ability to work within teams, including collaborating with colleagues, maintaining partnerships with other departments, serving on cross-functional teams, as well as cross divisional teams (Co-development). The candidate will also participate on sub-teams to achieve consensus for regulatory issues. Must have the ability to establish and maintain appropriate timelines to meet submission milestones and manage operational resources for specific projects/products to ensure delivery of submission-ready dossiers and documents on time in accordance with global RA CMC expectations/standards. Demonstration of an ability to handle several projects simultaneously under minimal supervision will be a key attribute of the successful candidate. Good negotiating skills.

Candidates with experience in a regulatory liaison role working directly with FDA (CVM) or other global Health Authorities in the area of biological, biopharmaceutical or pharmaceutical registration and compliance is highly desirable.

Experience in using problem-solving skills to propose and evaluate regulatory solutions to CMC issues and manage the preparation of contingency plans to meet the objectives of the Business in a highly competitive market. Must be able to apply high level informatics and document management skills within a matrix, cross divisional environment. Must demonstrate integrity in all areas of the work environment; assess business and scientific ethics for all regulatory decisions and strategic plans.

Other Attributes Desirable:

*Experience in genetic engineering, bioprocessing, protein analysis, microbiology, and development activities for products in support of the preparation and submission of regulatory CMC dossiers to meet global business objectives and Health Authority requirements.

* Understanding of GMPs for sterile and non-sterile manufacturing

* Understanding of global standards for analytical testing

* Very self-directed - can work with little supervision on most tasks

* Excellent organization, prioritization, and time management skills can work effectively under pressure

* Excellent written and oral communication skills

* Experience with an animal health portfolio

* Manage and adapt to change

Full time



Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of @zoetis.com . In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Keywords: Zoetis, Inc., Kalamazoo , Manager/ Assoc Director Regulatory Affairs CMC, Executive , Kalamazoo, Michigan

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

General Manager
Description: Used car dealership looking for an experienced
Company: CARite
Location: Kalamazoo
Posted on: 09/23/2019

General Manager - Hampton Inn South Bend
Description: ul li Managing budgets and financial plans and controlling expenditure li Maintaining statistical and financial records li Setting and achieving sales and profit targets li Recruiting, training, (more...)
Company: Hampton Inn & Suites South Bend
Location: South Bend
Posted on: 09/24/2019

Core Systems Product Manager - Mortgage
Description: Configuration and maintenance of external products, services, and fees in respective systems including application functionality, business requirements, performing QA testing and coordinate User Acceptance (more...)
Company: Arbor Financial Credit Union
Location: Kalamazoo
Posted on: 09/24/2019

Network Performance Director
Description: We Help People Live their Lives to the Fullest Potential br br For more than 30 years, Beacon has changed the way people live with behavioral health conditions. Today, we are the undisputed leader (more...)
Company: Beacon Health Options
Location: Grand Rapids
Posted on: 09/24/2019

Dispensary (Provisioning Center) Manager
Description: Company: br Fluresh is a premium vertically integrated medical cannabis company obsessed with quality and wellness. br We believe that each individual connection between a patient and cannabis is (more...)
Company: Fluresh
Location: Grand Rapids
Posted on: 09/23/2019

Director of Human Resources
Description: Leadership: Provide proactive leadership in the development, coordination and implementation of all Human Resource related functions including talent recruitment and retention, employee relations, salary (more...)
Company: Progressive AE
Location: Grand Rapids
Posted on: 09/23/2019

Front Desk Manager
Description: The Radisson Hotel Lansing at the Capitol, located in the heart of downtown Lansing, is currently looking for a Front Desk Manager to join its management team. The Front Desk Manager will be responsible (more...)
Company: Radisson Hotel Lansing at the Capitol
Location: Lansing
Posted on: 09/23/2019

Automation Manager (Engineering)
Description: The--Automation Engineering Manager--will be a critical hire for this team. It's a newly created opening to support growth, but also support/enhance all existing areas of business too 30 year history (more...)
Company: Job Juncture
Location: South Bend
Posted on: 09/23/2019

Personal Lines Account Manager
Description: Personal Lines Account Manager candidate will be a self-starter, well organized, highly detailed, possess
Company: Patra Corp
Location: Fort Wayne
Posted on: 09/23/2019

Clinical Trial Manager
Description: Background: The company is a large Medical Device company who is going to be starting a clinical trial for a Digital Pathology product. They need a Clinical Trial Manager
Company: LS Solutions
Location: Kalamazoo
Posted on: 09/24/2019

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Kalamazoo RSS job feeds