Director - Global CMC Strategy (Eye Care)
To see similar active jobs please follow this link: Remote Management jobs
Oyster Point Pharma, Inc (Delaware corp)
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.
Every day, we rise to the challenge to make a difference and here’s how the Director, Global CMC Strategy (Eye Care) role will make an impact:
Key responsibilities for this role include:
To guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris’ eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses.
Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensuring an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership.
Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation, as applicable.
Ensures lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently.
Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.
Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.
Supporting regulatory Due Diligence activities for business development opportunities.
Provide input to and adhere to departmental budget.
The minimum qualifications for this role are:
Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration.
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years
High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.
Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of eyecare products and product development an advantage.
Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.
Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.
Advanced skills in written & oral communications (mandatory).
Computer literacy with Microsoft Office Suite and Documentum-based applications.
Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager.
Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.
Demonstrated commitment and dedication to scientific and regulatory integrity, as well as quality compliance.
Ability to engage in the external regulatory and pharmaceutical environment.
Proven ability to deliver to time, cost and quality standards.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Position functions autonomously, with minimal supervision.
Typically sitting at a desk or table. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary – Minimal handling of light materials, lifting up to 10 lbs. Periodic travel may be required.
Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00 USD.
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. All 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.
#LI-Remote
About the job
Director - Global CMC Strategy (Eye Care)
To see similar active jobs please follow this link: Remote Management jobs
Oyster Point Pharma, Inc (Delaware corp)
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.
Every day, we rise to the challenge to make a difference and here’s how the Director, Global CMC Strategy (Eye Care) role will make an impact:
Key responsibilities for this role include:
To guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris’ eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses.
Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensuring an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership.
Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation, as applicable.
Ensures lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently.
Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.
Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.
Supporting regulatory Due Diligence activities for business development opportunities.
Provide input to and adhere to departmental budget.
The minimum qualifications for this role are:
Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration.
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years
High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.
Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of eyecare products and product development an advantage.
Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.
Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.
Advanced skills in written & oral communications (mandatory).
Computer literacy with Microsoft Office Suite and Documentum-based applications.
Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager.
Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.
Demonstrated commitment and dedication to scientific and regulatory integrity, as well as quality compliance.
Ability to engage in the external regulatory and pharmaceutical environment.
Proven ability to deliver to time, cost and quality standards.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Position functions autonomously, with minimal supervision.
Typically sitting at a desk or table. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary – Minimal handling of light materials, lifting up to 10 lbs. Periodic travel may be required.
Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00 USD.
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. All 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.
#LI-Remote