Regulatory Affairs Specialist

at  Viatris

Mylan Teoranta
At VIATRIS, we see healthcare not as it is but as it should be. We 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.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
The Regulatory Affairs Specialist will be responsible for the preparation of and contribution to regulatory submissions for parenteral pharmaceutical products for the US and International markets. This includes compilation and review of technical information for new product submissions, maintenance of existing product licenses and managing change controls for pending and approved products

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact:

• Life cycle management and regulatory filing maintenance activities;
• Preparation, review and scheduling submission of FDA required Annual Reports for Abbreviated New Drug and New Drug Applications for Mylan Institutional including scheduling and coordinating receipt of documentation/information, preparing cover letters, describing changes made to the application, and tracking progress of their preparation, with guidance from Senior Personnel. This also includes the review of documents, and utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements. Failure to prepare accurate and timely Annual Reports could result in FDA action which may include the removal of products from the marketplace.
• Preparation, review and scheduling submission of amendments and supplements/variations to product marketing applications, under guidance.
• New Product Submission Activities;
• Preparation of registration submissions, in eCTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required, with guidance from Senior Personnel.
• Support monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
• Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies, prepare and schedule the submission of associated amendments / variations / supplements as required.
• Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
• Actively participate in project teams, as required.
• Research information pertaining to marketing applications for other departments through the navigation of existing submissions and associated comments and regulatory documentation system.
• Maintain current knowledge of regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the Health Authority websites and attendance at conferences.
• Perform other duties as assigned.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelor’s degree (or equivalent) in a science related discipline and 2-3 years’ experience in the pharmaceutical industry. Regulatory experience an advantage.
• a strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidance’s for Industry (particularly those dealing with sterile products).
• Knowledge of the regulatory process pertaining to drug development, registration, review and approval.
• Knowledge of parenteral product.
• Experience in writing and reviewing scientific documentation for regulatory submissons.
• Knowledge of cGMP awareness and compliance.
• Knowledge of sterile products and their unique regulatory requirements would be an advantage

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme *
• Health insurance *
• Pension *

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
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 Employer.

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact:

• Life cycle management and regulatory filing maintenance activities;
• Preparation, review and scheduling submission of FDA required Annual Reports for Abbreviated New Drug and New Drug Applications for Mylan Institutional including scheduling and coordinating receipt of documentation/information, preparing cover letters, describing changes made to the application, and tracking progress of their preparation, with guidance from Senior Personnel. This also includes the review of documents, and utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements. Failure to prepare accurate and timely Annual Reports could result in FDA action which may include the removal of products from the marketplace.
• Preparation, review and scheduling submission of amendments and supplements/variations to product marketing applications, under guidance.
• New Product Submission Activities;
• Preparation of registration submissions, in eCTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required, with guidance from Senior Personnel.
• Support monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
• Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies, prepare and schedule the submission of associated amendments / variations / supplements as required.
• Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
• Actively participate in project teams, as required.
• Research information pertaining to marketing applications for other departments through the navigation of existing submissions and associated comments and regulatory documentation system.
• Maintain current knowledge of regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the Health Authority websites and attendance at conferences.
• Perform other duties as assigned

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelor’s degree (or equivalent) in a science related discipline and 2-3 years’ experience in the pharmaceutical industry. Regulatory experience an advantage.
• a strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidance’s for Industry (particularly those dealing with sterile products).
• Knowledge of the regulatory process pertaining to drug development, registration, review and approval.
• Knowledge of parenteral product.
• Experience in writing and reviewing scientific documentation for regulatory submissons.
• Knowledge of cGMP awareness and compliance.
• Knowledge of sterile products and their unique regulatory requirements would be an advantag