Job details
Job type full-time
Full job description
7100 mylan institutional inc.
At viatris, we see healthcare not as it is but as it should beWe act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – providing high quality trusted medicines regardless of geography or circumstance;
Leadership – advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the manager regulatory affairs role will make an impact:
Key responsibilities for this role include:
Liase/communicate with regulatory contacts at third party manufacturing sites to track review progress and enable timely issuance of required submission documentation.
Supervise, review and approve the preparation of regulatory submissions for pharmaceutical and combination products while managing adherence to the regulatory affairs schedule for applications and responsesEnsuring that required documentation is submitted in a timely and appropriate manner and that all regulatory requirements and/or commitments are met.
Ensure maintenance activities, including annual reports, are compliant and submitted on time, with appropriate tracking and monitoring of change using the trackwise system.
Determine risks to successful submission and approval, and documenting and communicating proposed mitigations and strategies to address these risks to senior leadershipProvide strategic recommendations and direction to technical team to reduce risks associated with submission and/or commercialization of products being developed.
Manage workload to ensure adherence to regulatory affairs schedule including timely responses to requests from regulatory authorities.
Communicate a clear view of regulatory requirements to project teams during major business, project, product or process changes, in collaboration with ra team and management.
Provide regulatory advice on anda submissions, approval and post-approval processes to product development, quality and manufacturing operations.
Research information pertaining to marketing applications for other departments using anda submissions and regulatory documentation systems.
Provide a critical detailed review of documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports.
Maintain current knowledge of regulations and other issues that affect products and the industryDisseminate and discuss with appropriate staff in a timely manner.
Perform other duties as assigned.
The minimum qualifications for this role are:
Must possess expert-level knowledge of the united states pharmacopoeia, title 21 of the code of federal regulations and various fda guidance’s for industry and have the ability to interpret these to apply to mylan proceduresMust also possess expert-level knowledge of the regulatory process pertaining to drug development, registration, review and approvalMust possess knowledge of mylan’s approach with regards to interactions with the fdaMust possess expert level knowledge of special requirements for sterile products.
Must possess strong analytical, organization, writing, and communication skillsMust have the ability to multi-task and have meticulous attention to detailMust possess strong computer skills and working knowledge of microsoft office suite, documentum, and lotus notesMust be able to manage various projects and employees in order to meet submission deadlines.
Position functions autonomously must possess knowledge of analytical chemistry, pharmaceutical industry practice, and fda regulations and guidance’s.
Position functions autonomously must possess knowledge of analytical chemistry, pharmaceutical industry practice, and fda regulations and guidance’s.
Bachelor`s degree (or equivalent) and 4-7 years of experienceHowever, a combination of experience and/or education will be taken into consideration.
Ability to read and interpret complex business and/or technical documentsAbility to write comprehensive reports and detailed business correspondenceAbility to work with managers or directors and communicate ambiguous conceptsAbility to present to groups across the organization.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysisAbility to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
At viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an equal opportunity employerAll qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
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