Director Regulatory Strategist
3 settimane fa
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
Include introductory paragraph here if available
Every day, we rise to the challenge to make a difference and here’s how the Director Regulatory Strategist role will make an impact:
Developing Global/Regional regulatory strategies and implementation plans for complex projects/products including novel, product enhancement and post approval products; Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.
Partnering with project teams and other stakeholders (e.g. Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure required regulatory contributions (briefing documents, Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and quality standards and are provided in accordance with agreed timelines.
Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development.
Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels as appropriate.
Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated.
Developing fit-for-purpose submission packages in collaboration with partner lines
Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed, communicated and executed on time to the required quality standards.
Developing and maintaining constructive working relationships with Health Authority contacts.
Supporting regulatory Due Diligence activities for business development opportunities.
Working closely with other Regulatory team members to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
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, Country Regulatory Leads and trade associations.
Ensuring business compliance and implementation of and adherence to regulatory standards.
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:
BS. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
Relevant Global and/or Regional regulatory experience
Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation.
Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including ability to manage complex regulatory issues. Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
Proven ability to deliver to time, cost, and quality standards.
Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other partner lines and senior stakeholders to achieve objectives.
Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Proven ability to deliver in a highly matrixed organization.
Strong written and verbal communication skills.
Desirable experience would include a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision.
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
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
At Viatris, we offercompetitivesalaries, benefitsandan 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.
-
Director Regulatory Strategist
3 settimane fa
Milan, Italia Viatris A tempo pienoVIATRIS ITALIA S.R.L.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...
-
Associate Director, Regulatory Affairs
2 settimane fa
Milan, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...
-
Associate Director, Regulatory Affairs
1 settimana fa
Milan, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...
-
Associate Director, Regulatory Affairs
1 settimana fa
Milan, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
-
Associate Director, Regulatory Affairs
6 giorni fa
Milan, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
-
Director, Regulatory Affairs
4 mesi fa
Milan, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve. We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to Managers and...
-
Account Manager
3 giorni fa
Milan, Italia Hangar Design Group A tempo pienoDESCRIZIONELavorando spesso con scadenze strette e supervisionando più progetti, l’Account Manager / Director deve essere un abile coordinatore di team creativi (tra cui, ma non solo: art director, copywriter, content strategist, grafici e designer). L’Account Manager / Director deve essere un comunicatore efficace, soprattutto quando si tratta di...
-
Medical Director, Rheumatology
2 settimane fa
Milan, Italia ICON plc A tempo pienoMedical Director, Rheumatology ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Rheumatologist to join our diverse and...
-
Principal Regulatory Affairs Consultant
2 mesi fa
Milan, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong...
-
Milan, Italia Control Risks A tempo pienoControl Risks is expanding its presence in Italy with the recent launch of a new entity and the opening of our Milan office. As part of our ongoing investment in the country, we are looking for an experienced professional to join our team as a Senior Consultant/Associate Director. In this pivotal role, you will be instrumental in enhancing Control Risks'...
-
Legal Director Renewables
4 mesi fa
Milan, Italia MET Group A tempo pienoJob Description Providing full-scope legal support to the Executive Chairman, the Renewables CEO and the origination, project development, construction and O&M teams in the Green Assets Division, Reviewing, drafting and negotiating a range of contracts to support the Green Assets Division in meeting their respective business growth strategies and...
-
Associate Director, Forensic Investigations
4 settimane fa
Milan, Italia Control Risks A tempo pienoControl Risks is expanding its presence in Italy with the recent launch of a new entity and the opening of our Milan office. As part of our ongoing investment in the country, we are looking for an experienced professional to join our team as a Senior Consultant/Associate Director. In this pivotal role, you will be instrumental in enhancing Control Risks'...
-
Legal Director Renewables
1 settimana fa
Milan, Italia MET Group A tempo pienoCompany DescriptionMET Group is an integrated European energy company, headquartered in Switzerland, with activities in natural gas and power, focused on multi-commodity wholesale, trading and sales, as well as energy infrastructure and industrial assets.The Green Assets Division's goal is to create a significant, transparent, financially sound green assets...
-
Legal Director Renewables
3 settimane fa
Milan, Italia MET Group A tempo pienoCompany DescriptionMET Group is an integrated European energy company, headquartered in Switzerland, with activities in natural gas and power, focused on multi-commodity wholesale, trading and sales, as well as energy infrastructure and industrial assets.The Green Assets Division's goal is to create a significant, transparent, financially sound green assets...
-
Engineering and Maintenance Director
1 settimana fa
Milan, Italia https:www.energyjobline.comsitemap.xml A tempo pienoEngineering and Maintenance DirectorWe are currently looking for an Engineering and Maintenance Director to join our team in Milan.Key Responsibilities:Maintenance Management:Develop and implement comprehensive maintenance programs for all engineering systems. Schedule and supervise preventive maintenance activities to minimize downtime and maximize...
-
Sr. Tipm
4 mesi fa
Milan, Italia Amazon EU SARL - D68 A tempo pienoAt Amazon we believe that Every Day is still Day One We’re working to be the most customer-centric company on earth. To get there, we need exceptionally talented, bright and driven people. We are looking for an expert Energy Market Advisor to lead our energy strategy and ensure the resilience of our energy supply. This role involves deep knowledge of...
-
Sr. TIPM
4 mesi fa
Milan, Italia Amazon EU SARL (Italy Branch) - D68 A tempo pienoAt Amazon we believe that Every Day is still Day One! We’re working to be the most customer-centric company on earth. To get there, we need exceptionally talented, bright and driven people.We are looking for an expert Energy Market Advisor to lead our energy strategy and ensure the resilience of our energy supply. This role involves deep knowledge of...
-
Sr. tipm
1 mese fa
Milan, Italia Amazon EU SARL - D68 A tempo pienoAt Amazon we believe that Every Day is still Day One We’re working to be the most customer-centric company on earth.To get there, we need exceptionally talented, bright and driven people.We are looking for an expert Energy Market Advisor to lead our energy strategy and ensure the resilience of our energy supply.This role involves deep knowledge of energy...
-
Medical Director- Oncology/Hematology
5 mesi fa
Milan, Italia IQVIA A tempo pienoJob Overview The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical...
-
Engineering and Maintenance Director
2 settimane fa
Milan, Italia https:www.energyjobline.comsitemap.xml A tempo pienoWe are currently looking for an Engineering and Maintenance Director to join our team in Milan.Key Responsibilities:Maintenance Management:Develop and implement comprehensive maintenance programs for all engineering systems.Schedule and supervise preventive maintenance activities to minimize downtime and maximize operational efficiency.Coordinate with...