Regulatory CMC Senior Associate II

Zoetis•Kalamazoo, MI

23h

About The Position

POSITION RESPONSIBILITIES: 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. Responsibilities will include, but not limited to: 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 liaison on Development teams in their efforts to deliver a quality 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. Other: 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%. EDUCATION AND EXPERIENCE: Minimum of a Bachelor degree with 7 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 Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications. 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 [email protected] 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. At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Requirements

Minimum of a Bachelor degree with 7 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.
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.

Nice To Haves

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

Responsibilities

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 liaison on Development teams in their efforts to deliver a quality 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.

Benefits

competitive healthcare and retirement savings benefits
array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources

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