Regulatory Affairs CMC Director for EU and ROW Products
1 week ago
We are seeking an experienced CMC Director to oversee the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for our products across the European Union and Rest of World. This role will involve building and maintaining collaborative relationships with product teams, particularly with members from Tech Ops and Quality.
The successful candidate will act as Senior Oversight for RA CMC activities, ensuring effective delivery of quality CMC support from vendors. They will also lead a team of permanent employees in CMC regulatory and supervise contractors and consultants supporting CMC regulatory objectives.
This role requires strategic thinking to ensure that RA CMC strategies fully recognize risk, provide mitigations, and communicate these within the organization for informed product team decision-making.
The CMC Director will be responsible for RA CMC focused agency negotiations and interactions, including scientific advice. They will lead their team to deliver assigned RA CMC objectives on their portfolio, ensuring team members have clear performance and development objectives.
About You- Hold a scientific-based degree
- Have proven pharmaceutical experience in regulatory or technical CMC
- Possess CMC technical experience
- Be able to drive efficient technical regulatory stewardship of products working collaboratively with internal and external partners
A competitive salary of approximately £80,000 - £110,000 per annum is available for this role, depending on experience. We also offer a flexible benefits package.
Diversity and InclusionMundipharma International prioritizes creating an inclusive environment where individuals can thrive, grow, and achieve their full potential. If you're interested in hearing about future opportunities at Mundipharma, consider joining our talent community.
-
CMC Regulatory Lead
1 week ago
Cambridge, Ontario, Canada Mundipharma International Full timeCMC Regulatory Lead for Marketed ProductsSalary: £80,000 - £110,000 per annum.This role is based in Cambridge, with some travel to the city when necessary. At Mundipharma International, we pride ourselves on bringing innovative treatments to patients worldwide. We strive to deliver more for our customers, healthcare professionals, partners, and...
-
Cambridge, Ontario, Canada Mundipharma International Full timeJob DescriptionMundipharma International is seeking an experienced Regulatory Affairs Director to lead the development and implementation of strategies for Chemistry, Manufacturing, and Controls (CMC) in marketed products across EU and ROW.This role requires a strong leader who can collaborate effectively with cross-functional teams, including Technical...
-
Regulatory Affairs CMC Director
3 weeks ago
Cambridge, Ontario, Canada Mundipharma International Full timeRegulatory Affairs CMC Director£80,000 - £110,000 per annumCambridge (Home working with some travels to Cambridge when needed)Job Description:This is a challenging and rewarding role as CMC Director where you will be responsible for efficiently managing and delivering Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across...
-
CMC Director for Global Marketed Products
4 weeks ago
Cambridge, Ontario, Canada Mundipharma International Full timeAbout the RoleMundipharma International is seeking a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW.Key ResponsibilitiesDevelop and implement RA CMC strategies for products, including oversight of vendor delivery.Ensure RA CMC strategies fully recognise...
-
Cambridge, Ontario, Canada Mundipharma International Full timeMarket Leaders in CMC ExpertiseWe are seeking a highly skilled Regulatory Affairs Chemistry Manufacturing Control (RA CMC) professional to lead our team in delivering exceptional outcomes for products across the EU and ROW.This role requires a strategic thinker with strong leadership skills, capable of building and maintaining collaborative partnerships with...
-
Regulatory Compliance Specialist
4 weeks ago
Cambridge, Ontario, Canada Clarion Medical Technologies Inc. Full timeClarion Medical Technologies, a leading innovator in surgical, vision, and aesthetic healthcare medical devices, offers an exciting opportunity for a Regulatory Compliance Specialist.With a competitive salary of $80,000 - $110,000 per year, this role is perfect for someone with a strong background in regulatory affairs and quality compliance. Located in...
-
Regulatory Compliance Specialist
3 weeks ago
Cambridge, Ontario, Canada Clarion Medical Technologies Inc. Full timeCompany Overview:Clarion Medical Technologies Inc. is a leading provider of surgical, vision, and aesthetic healthcare medical devices in Canada.We specialize in laser technologies, diagnostic tools for early disease detection, and advanced imaging systems. Our mission is to empower healthcare providers with the tools and expertise to deliver outstanding...
-
Regulatory Affairs Manager
1 month ago
Cambridge, Ontario, Canada The MEARIE Group Full timeAbout the RoleThe Manager Regulatory Affairs & Revenue Assurance at The MEARIE Group will lead a team of regulatory analysts and oversee the preparation and management of regulatory filings and proceedings. This senior role will actively participate in the development and implementation of the Company's regulatory strategy and ensure compliance with...
-
Cambridge, Ontario, Canada The MEARIE Group Full timeCompany Overview:GrandBridge Energy Inc. (GBE) is a leading energy transformation company driven by a mission to bridge communities to the energy future. With over 113,000 customers across Brantford, Cambridge, North Dumfries, and Brant, GBE provides safe and reliable electricity while navigating the transition towards a dynamic and evolving energy...
-
Caregiving Professional
1 week ago
Cambridge, Ontario, Canada peopleCare Communities Full timeCommunity Care Nursing PositionWe are thrilled to be named one of Canada's Best Managed Companies for the eleventh year in a row.This award recognizes top companies across Canada for overall performance, sustained growth, strategy, capabilities and innovation, culture and commitment, and leadership.In this position, you will work under the direction of the...
-
Executive Director, Risk and Compliance Officer
3 weeks ago
Cambridge, Ontario, Canada Cowan Insurance Group Full timeCowan Insurance Group seeks an experienced Executive Director to lead its risk and compliance functions.As a key member of the senior leadership team, you will oversee the development and implementation of comprehensive risk management strategies that align with the company's overall business objectives.The successful candidate will have a proven track...
-
Strategic Product Development Director
3 weeks ago
Cambridge, Ontario, Canada Lone Wolf Real Estate Technologies Inc Full timeWe are seeking a highly motivated and experienced Strategic Product Development Director to lead our product operations internally.As a key member of the Lone Wolf R&D team, you will interact with various stakeholders including Product Directors, Product Owners, Developers, Sales, Support, and users to determine their needs and develop effective product...
-
Product Director of Service Solutions
1 month ago
Cambridge, Ontario, Canada ATS Automation Full timeAbout the RoleATS Automation is seeking a Product Director of Service Solutions to drive the success and profitability of its Services portfolio globally. The successful candidate will define a vision and roadmap for products and solutions, from conception to launch, and manage the lifecycle of services offers.This leadership role bridges the gap among...
-
Product Quality Specialist
4 weeks ago
Cambridge, Ontario, Canada Virbac Full timeAbout the RoleWe are seeking a highly skilled Product Quality Specialist to join our team at Virbac in Canada. As a Product Quality Specialist, you will play a critical role in ensuring the quality and regulatory compliance of products manufactured and distributed in the Canadian market.Job DescriptionThe Product Quality Specialist will be responsible...
-
Asset Management Director
1 week ago
Cambridge, Ontario, Canada Allergan Full timeWe are seeking an experienced Asset Management Director to join our team at AbbVie. This role will involve conceiving, executing, and managing clinical pharmacology development plans and strategies to achieve commercial goals and regulatory requirements.Key ResponsibilitiesClinical Pharmacology Strategy Development: Lead the development of multi-disciplinary...
-
Manufacturing Operations Director
2 weeks ago
Cambridge, Ontario, Canada itec group, Inc. Full timeJob Summary:We are seeking a seasoned Manufacturing Operations Director to lead our Brantford, ON plant. As a key member of our team, you will oversee all aspects of plant operations, ensuring production goals are met while maintaining the highest standards for safety, quality, and efficiency.About the Role:Operations Management:Oversee day-to-day operations...
-
Regional Quality Assurance Director
3 weeks ago
Cambridge, Ontario, Canada Babcock and Wilcox Full timeJob Title: Regional Quality Assurance DirectorOverview:Babcock and Wilcox is seeking a skilled and experienced Regional Quality Assurance Director to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our quality program is effectively implemented in the assigned region, meeting all required...
-
Supply Chain Operations Director
3 weeks ago
Cambridge, Ontario, Canada Dimplex North America Ltd. Full timeWe are seeking a highly skilled and experienced Supply Chain Operations Director to join our team at Dimplex North America Ltd. in Mississauga, Ontario. The ideal candidate will have a strong background in logistics and supply chain management, with a proven track record of driving operational excellence and cost savings.The estimated salary for this role is...
-
Chief Administrative Operations Director
4 weeks ago
Cambridge, Ontario, Canada MATRIC SECURITY Full timeJob TitleChief Administrative Operations DirectorAbout the RoleWe are seeking a highly skilled and experienced Chief Administrative Operations Director to lead our administrative services. As a key member of our team, you will be responsible for planning, organizing, directing, controlling, and evaluating daily operations.ResponsibilitiesAdministrative...
-
Packaging Production Specialist
3 weeks ago
Cambridge, Ontario, Canada OPW Full timeThe Packaging Production Specialist is a critical role at OPW, responsible for ensuring the efficient and safe operation of our packaging equipment.This position plays a key part in meeting production targets, maintaining a clean and organized work environment, and adhering to safety protocols and quality standards.Key responsibilities include operating...