Director Respiratory Bioequivalence Strategy Lead
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What you'll do
- Leads bioequivalence strategy input to project teams, developing and leading the execution of technical strategies to understand and optimize in-vitro product attributes determining in-vivo performance.
- Partners with pre-clinical and clinical leads within project teams to define pre-clinical and/or clinical studies required to support product development to meet bioequivalence requirements.
- Ensures high quality technical reports are generated that interpret scientific outcomes in the context of key technical decision-making.
- Makes technical recommendations on product development activities in the context of project and regulatory objectives for achieving bioequivalence, including where appropriate, development of analytical methodology, introduction of new technology and authoring of technical elements of regulatory submissions.
- Provides briefings to function/vertical managers and the wider development team and presents data at technical meetings and project team meetings.
- Uses expertise to work with colleagues to write regulatory correspondence describing complex strategies and subsequently represent Viatris at regulatory authority meetings as required.
- Collaborates with statistics SMEs to ensure that appropriate statistical tools and methodologies are applied to support product development and regulatory filings.
- Maintains current awareness of scientific developments relevant to respiratory product development and in-vivo performance and provides clear business rationale for implementation.
- Maintains current awareness of relevant regulatory authority guidance and positions with respect to bioequivalence and in-vitro/in-vivo relationships and works with regulatory colleagues to influence these.
- Contributes where appropriate to relevant cross-industry and regulatory working groups. Uses expertise to represent Viatris externally as a scientific leader on relevant topics.
- Mentors individuals working on bioequivalence tests to deepen general understanding of scientific issues and principles underlying respiratory product development for in-vitro equivalence and in-vivo performance.
- As a leading member of the bioequivalence strategy function, contributes to strategic and operational development of group capabilities.
What they're looking for
- Degree or equivalent in a life science or related discipline
- Experience in the development and/or application of analytical tests used in bioequivalence studies and in support of product development targeting in-vivo bioequivalence.
- Experience in contributing to regulatory submissions for respiratory and/or other complex products.
- Experience of external influencing either in cross-industry forums or with regulatory agencies.
- Knowledge of development of inhaled products and the challenges associated with their commercialization.
- Understanding of regulatory guidelines for respiratory products & their interpretation in developing new and generic products.
- Understanding of the challenges associated with biopharmaceutics and bioequivalence strategies for respiratory products.
- Knowledge of the key aspects of related / interface disciplines such as formulation, clinical, device.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Every day, we rise to the challenge to make a difference, and here’s how the Director Respiratory Bioequivalence Strategy Lead role will make an impact: Responsible for ensuring respiratory product development programmes include appropriate studies to meet regulatory bioequivalence requirements
Key responsibilities for this role include:
Leads bioequivalence strategy input to project teams, developing and leading the execution of technical strategies to understand and optimize in-vitro product attributes determining in-vivo performance.
Partners with pre-clinical and clinical leads within project teams to define pre-clinical and/or clinical studies required to support product development to meet bioequivalence requirements.
Ensures high quality technical reports are generated that interpret scientific outcomes in the context of key technical decision-making.
Makes technical recommendations on product development activities in the context of project and regulatory objectives for achieving bioequivalence, including where appropriate, development of analytical methodology, introduction of new technology and authoring of technical elements of regulatory submissions. .
Provides briefings to function/vertical managers and the wider development team and presents data at technical meetings and project team meetings.
Uses expertise to work with colleagues to write regulatory correspondence describing complex strategies and subsequently represent Viatris at regulatory authority meetings as required.
Collaborates with statistics SMEs to ensure that appropriate statistical tools and methodologies are applied to support product development and regulatory filings.
Maintains current awareness of scientific developments relevant to respiratory product development and in-vivo performance and provides clear business rationale for implementation.
Maintains current awareness of relevant regulatory authority guidance and positions with respect to bioequivalence and in-vitro/in-vivo relationships and works with regulatory colleagues to influence these.
Contributes where appropriate to relevant cross-industry and regulatory working groups. Uses expertise to represent Viatris externally as a scientific leader on relevant topics.
Mentors individuals working on bioequivalence tests to deepen general understanding of scientific issues and principles underlying respiratory product development for in-vitro equivalence and in-vivo performance.
As a leading member of the bioequivalence strategy function, contributes to strategic and operational development of group capabilities.
Adheres to all applicable policies and procedures, including those relating to EHS, GMP, GCP, Quality and Compliance, consistent with the role and any associated responsibilities, including people management where applicable.
The minimum qualifications for this role are:
Degree or equivalent in a life science or related discipline
Experience in the development and/or application of analytical tests used in bioequivalence studies and in support of product development targeting in-vivo bioequivalence.
Experience in contributing to regulatory submissions for respiratory and/or other complex products.
Experience of external influencing either in cross-industry forums or with regulatory agencies.
Knowledge of development of inhaled products and the challenges associated with their commercialization.
Understanding of regulatory guidelines for respiratory products & their interpretation in developing new and generic products.
Understanding of the challenges associated with biopharmaceutics and bioequivalence strategies for respiratory products.
Knowledge of the key aspects of related / interface disciplines such as formulation, clinical, device.
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.
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.
Company
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