Dechra Pharmaceuticals PLC
Principal Scientist, Regulatory Affairs CMC
Dechra Pharmaceuticals PLC, Portland, Maine, us, 04122
Vacancies
Principal Scientist, Regulatory Affairs CMC
Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business.
Role Responsibility
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:Provides effective Regulatory CMC representation for development projects and commercial stage products, and acts as a key player in interactions with regulatory agencies on CMC related topics, in collaboration with global regulatory teams.Effectively interprets and applies regulatory guidance and provides regulatory recommendations and solutions to key stakeholders.Drives alignment of regulatory CMC strategy within the RA department and other functions. Effectively communicates regulatory strategy consistently to stakeholders.Actively collaborates with Global Regulatory CMC, Product Development teams, Technical Operations (internal and external manufacturing), and Quality to develop and execute robust regulatory strategies and risk mitigation for product development, registration, and post-marketing life cycle management.Leads and manages the development and preparation of CMC-related submission documents and ensures they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but are not limited to, new drug applications (e.g. NADA, ANADA, etc.) in the Common Technical Documents (CTD) format, investigational new animal drug applications (e.g. INAD, JINAD), supplemental filings (e.g. PAS, CBE), responses to agency comments, and annual reports.Leads best practices for regulatory CMC compliance activities in cooperation with local and global Quality including, but not limited to, change controls, post-marketing commitments, product quality complaints, and regulatory inspections.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:A minimum of 6-8 years in CMC regulatory affairs within the pharmaceutical industry, specifically with US-FDA regulations (CVM experience preferred).Strong understanding of GMP standards and FDA regulatory requirements for CMC.Ability to work methodically and flexibly, with a proven capacity to set up and maintain both manual and electronic filing systems.Exceptional attention to detail, with strong decision-making skills and resourcefulness.Effective listening, verbal, and written communication skills, with the capability to confidently and credibly deliver internal and external presentations.Excellent interpersonal skills to establish and maintain effective relationships at all levels.Proven ability to plan, organize, and prioritize workload independently to meet deadlines, including support for supply chain maintenance.Strong ability to manage and progress multiple projects concurrently.Demonstrates respect, sensitivity, and professionalism in interactions with colleagues and external partners.Maintains a high level of confidentiality and discretion.Ability to lead project teams and mentor/train less experienced colleagues.Shows initiative in seeking knowledge and learning independently.
About the Company
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 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.#J-18808-Ljbffr
Principal Scientist, Regulatory Affairs CMC
Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business.
Role Responsibility
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:Provides effective Regulatory CMC representation for development projects and commercial stage products, and acts as a key player in interactions with regulatory agencies on CMC related topics, in collaboration with global regulatory teams.Effectively interprets and applies regulatory guidance and provides regulatory recommendations and solutions to key stakeholders.Drives alignment of regulatory CMC strategy within the RA department and other functions. Effectively communicates regulatory strategy consistently to stakeholders.Actively collaborates with Global Regulatory CMC, Product Development teams, Technical Operations (internal and external manufacturing), and Quality to develop and execute robust regulatory strategies and risk mitigation for product development, registration, and post-marketing life cycle management.Leads and manages the development and preparation of CMC-related submission documents and ensures they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but are not limited to, new drug applications (e.g. NADA, ANADA, etc.) in the Common Technical Documents (CTD) format, investigational new animal drug applications (e.g. INAD, JINAD), supplemental filings (e.g. PAS, CBE), responses to agency comments, and annual reports.Leads best practices for regulatory CMC compliance activities in cooperation with local and global Quality including, but not limited to, change controls, post-marketing commitments, product quality complaints, and regulatory inspections.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:A minimum of 6-8 years in CMC regulatory affairs within the pharmaceutical industry, specifically with US-FDA regulations (CVM experience preferred).Strong understanding of GMP standards and FDA regulatory requirements for CMC.Ability to work methodically and flexibly, with a proven capacity to set up and maintain both manual and electronic filing systems.Exceptional attention to detail, with strong decision-making skills and resourcefulness.Effective listening, verbal, and written communication skills, with the capability to confidently and credibly deliver internal and external presentations.Excellent interpersonal skills to establish and maintain effective relationships at all levels.Proven ability to plan, organize, and prioritize workload independently to meet deadlines, including support for supply chain maintenance.Strong ability to manage and progress multiple projects concurrently.Demonstrates respect, sensitivity, and professionalism in interactions with colleagues and external partners.Maintains a high level of confidentiality and discretion.Ability to lead project teams and mentor/train less experienced colleagues.Shows initiative in seeking knowledge and learning independently.
About the Company
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 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.#J-18808-Ljbffr