Biologics CMC Regulatory Affairs Director
4 days ago
Dechra Pharmaceuticals PLC is seeking a highly skilled Biologics CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA, and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs.
Key Responsibilities:- Develop and implement CMC global regulatory strategies, ensuring technical accuracy and regulatory compliance while adhering to timelines and e-submission requirements.
- Collaborate closely with Dechra's other regulatory team members to devise robust global regulatory CMC strategies and risk mitigation for FDA, USDA, and other agency regulated programs.
- Engage in effective communication and collaboration with cross-functional teams, within CMC and with Clinical, to coordinate efforts and achieve regulatory compliance and operational excellence.
- Support preparation of comprehensive and stage-appropriate briefing books to enable regulatory agency interactions for CMC-related questions and topics.
- Work with quality lead and conduct assessments of change controls and deliver regulatory evaluations of quality changes in production and quality control.
- 9+ years of industry experience in CMC regulatory function
- Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D
- Proficiency and hands-on experience in regulatory submission and approval processes from new product development to commercialization
- Proven ability to navigate complex CMC regulatory issues and requirements effectively
- Previous regulatory experience in biologics development, especially in monoclonal antibody-based products is preferred
- Knowledge of animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies is essential
- Extensive track record in the development and maintenance of regulatory CMC documents, with a strong command of regulatory standards and requirements
As a people-first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial, and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
-
Regulatory Affairs Director
4 days ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Dechra Pharmaceuticals PLC. As a key member of our regulatory team, you will be responsible for developing and executing successful regulatory strategies to achieve agreed project goals, ultimately leading to regulatory approvals.Key...
-
Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra group Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra Group. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
-
Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra group Full timeChief Development OfficerThis is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra, is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform...
-
Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra group Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra Group. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
-
Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeAbout the RoleWe are seeking a highly experienced Chief Development Officer to join our team at Dechra Pharmaceuticals PLC. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
-
Chief Development Officer
4 days ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra Pharmaceuticals PLC. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute...
-
Chief Development Officer
3 days ago
Natick, Massachusetts, United States Dechra group Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra group. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
-
Commercial Banking Director
6 days ago
Natick, Massachusetts, United States BankTalent HQ Full timeJob SummaryWe are seeking a highly skilled and experienced Commercial Banking Director to lead our Commercial Lending Team. The ideal candidate will have a strong background in commercial lending, excellent analytical and organizational skills, and the ability to develop and implement effective business strategies.Key ResponsibilitiesDevelop and implement...
-
Commercial Banking Director
3 weeks ago
Natick, Massachusetts, United States Middlesex Savings Bank Full timeJob SummaryWe are seeking a highly experienced and skilled Commercial Banking Director to lead our Commercial Lending Team at Middlesex Savings Bank. The ideal candidate will have a strong background in commercial lending, excellent leadership skills, and a proven track record of driving business growth and development.Key ResponsibilitiesTeam Leadership:...
-
Medical Director
3 weeks ago
Natick, Massachusetts, United States Direct Jobs Full timeJob SummaryWe are seeking a highly skilled and experienced Medical Director to join our team at Boston West. As a key member of our leadership team, you will be responsible for overseeing medical operations, ensuring the highest quality of patient care, and driving clinical excellence.Key ResponsibilitiesMedical QualityDevelop and maintain medical policies...
-
Supply Chain Manager
7 days ago
Natick, Massachusetts, United States Intuvie Full timeJob Title: Supply Chain ManagerIntuvie is seeking a highly skilled Supply Chain Manager to oversee the end-to-end management of international shipments, ensuring the efficient and compliant movement of medical devices and administration sets.Key Responsibilities:Procurement and Supplier Coordination:Oversee procurement processes for medical devices and...
-
Executive Director of Business Development
3 weeks ago
Natick, Massachusetts, United States Nona Biosciences Full timeAbout the RoleNona Biosciences is seeking a seasoned professional to fill the position of Senior Director - Vice President, Business Development. This strategic role will play a crucial part in driving the company's growth and success in the biotech industry.Key ResponsibilitiesBusiness Strategy Development: Develop and execute the company's business...
-
Epidemiology Expert
3 weeks ago
Natick, Massachusetts, United States Exponent Full timeAbout Exponent: Exponent is a leading engineering and scientific consulting firm that empowers clients to create a safer, healthier, and more sustainable world. Our multidisciplinary teams of experts in science, engineering, and regulatory affairs collaborate to deliver innovative solutions to complex challenges. We are committed to attracting and developing...
-
Social Work Lead
2 weeks ago
Natick, Massachusetts, United States Tenet Massachusetts Full timeJob Title: Social Work LeadTenet Massachusetts is seeking a highly skilled Social Work Lead to join our team in Natick, Massachusetts.Job SummaryThe Social Work Lead will be responsible for facilitating care along a continuum through effective resource coordination to help patients achieve optimal health, access to care, and appropriate utilization of...
-
Natick, Massachusetts, United States Aurora Counseling Associates, LLC Full timePosition OverviewAurora Counseling Associates, LLC is seeking independently licensed clinicians at the Master's and Doctoral levels to deliver both telehealth and face-to-face psychotherapy services. We pride ourselves on being a woman-owned, established practice that values inclusivity, leadership in service, and clinical excellence.We encourage...
-
Licensed Psychotherapist for Dynamic Practice
4 weeks ago
Natick, Massachusetts, United States Aurora Counseling Associates, LLC Full timePosition OverviewAurora Counseling Associates, LLC is seeking licensed mental health professionals at the Master's and Doctoral levels to deliver both telehealth and in-person psychotherapy services. We pride ourselves on being a woman-owned practice that fosters a culture of inclusivity, clinical excellence, and leadership in service.We are particularly...
-
Medical Claims Processing Associate
1 month ago
Natick, Massachusetts, United States Roessel Joy Full timeJob OverviewRoessel Joy is in search of a Medical Billing Clerk to join our dynamic team. The ideal candidate will possess a solid understanding of medical coding and billing processes within a healthcare setting, alongside familiarity with medical terminology and experience with billing software such as Epic or CareTracker.Key Responsibilities:Claims...
-
Healthcare Billing Specialist
1 month ago
Natick, Massachusetts, United States Roessel Joy Full timeJob OverviewRoessel Joy is in search of a Medical Billing Clerk to join our dynamic team. The ideal candidate will possess a solid understanding of medical coding and billing practices within a healthcare setting, along with familiarity with medical terminology and experience using billing software such as Epic or CareTracker.Key Responsibilities:Claims...
-
Chief Development Officer
8 hours ago
Natick, United States Dechra group Full timeThis is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading...
-
Supply Chain Manager
2 days ago
Natick, United States Intuvie Full timeGENERAL SUMMARYINTUVIE seeks a Supply Chain Manager that will oversee the end-to-end management of international shipments, ensuring the efficient and compliant movement of medical devices and administration sets. This role involves strategic planning, supplier management, and logistics coordination, with a strong emphasis on regulatory compliance and...
-
Supply Chain Manager
1 week ago
Natick, United States Intuvie Full timeGENERAL SUMMARYINTUVIE seeks a Supply Chain Manager that will oversee the end-to-end management of international shipments, ensuring the efficient and compliant movement of medical devices and administration sets. This role involves strategic planning, supplier management, and logistics coordination, with a strong emphasis on regulatory compliance and...
-
Environmental Toxicologist
3 weeks ago
Natick, Massachusetts, United States Exponent Inc. Full timeAbout Exponent Inc.We are a leading engineering and scientific consulting firm that provides expert solutions to complex challenges. Our team of experts is committed to delivering high-quality services that create a safer, healthier, and more sustainable world.Our OpportunityWe are seeking an Environmental Toxicologist to join our team in our Natick, MA...
-
Lead Technician
2 weeks ago
Natick, Massachusetts, United States Chenega Corporation Full timeJob SummaryWe are seeking a highly skilled Lead Technician to join our team at Chenega Corporation. As a Technical Team Leader, you will be responsible for coordinating the workload of the Technical Team and providing daily guidance and direction.Key ResponsibilitiesAssist the Project Director in briefings and demonstrations of the program across the...
-
Doctor of Physical Therapy
4 weeks ago
Natick, United States FlexPlus Physical Therapy Full timeJob DescriptionJob DescriptionBenefits:401(k)401(k) matchingBonus based on performanceCompetitive salaryDental insuranceHealth insuranceOpportunity for advancementPaid time offTuition assistance FlexPlus Physical Therapy is a premier provider of orthopedic, vestibular, and pelvic floor physical therapy care in Natick, MA, dedicated to delivering exceptional...
-
Master of Social Work at Tenet Massachusetts
2 weeks ago
Natick, United States Tenet Massachusetts Full timeTenet Massachusetts is seeking a Social Work Master of Social Work Lead for a job in Natick, Massachusetts.Job Description & RequirementsSpecialty: Master of Social WorkDiscipline: Social WorkDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffLead Social Worker Full Time DaysJob Details$15K SIGN-ON BONUS for External...
-
Senior DEI Program Manager
4 weeks ago
Natick, United States W.T. Rich Company Full timeSenior DEI Program ManagerThe Senior DEI Program Manager will hold a pivotal role in spearheading the development and execution of W.T. Rich’s diversity, equity, and inclusion initiatives. This position will oversee the management and implementation of programs and strategies aimed at fostering a diverse and inclusive culture across project job sites and...
-
Senior DEI Program Manager
4 weeks ago
Natick, United States W.T. Rich Company Full timeSenior DEI Program ManagerThe Senior DEI Program Manager will hold a pivotal role in spearheading the development and execution of W.T. Rich’s diversity, equity, and inclusion initiatives. This position will oversee the management and implementation of programs and strategies aimed at fostering a diverse and inclusive culture across project job sites and...
-
Dispensary Inventory Shift Lead
2 months ago
Natick, United States Redi Cannabis Full timeJob DescriptionJob DescriptionTitle: Inventory Shift Lead The Inventory Shift Lead is responsible and accountable for all aspects of quality control, products entering and leaving the Vault and assisting with managing the Inventory Specialist team including receiving wholesale deliveries. Authority and supervision:Reports Directly to the General Manager,...