Mgr, Regulatory Consulting (non-clinical)

📁
Consulting
📅
20004463 Requisition #
Regulatory Manager – Non Clinical

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 23,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Summary:
Provide regulatory and nonclinical technical support for assigned product development projects, including product development documents and regulatory agency submissions to FDA, EMA, and Health Canada in CTD compliant format, and interact and collaborate with project teams on client projects.



Essential Functions:

• Author or review nonclinical sections of regulatory documents, such as investigator's brochures, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs).

• Summarize pharmacology, pharmacokinetics and toxicology data and prepare briefing packages for regulatory agency meetings or advice.

• Conduct literature search and draft safety assessments of active ingredients, impurities and excipients.

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans.

• Contribute to or prepare responses to requests for nonclinical information to worldwide health authorities.

• Assist with nonclinical pharmacology and toxicology program reviews for drugs and biologics to ensure scientific merit and regulatory compliance.

• Assist the Head of Global Regulatory Consulting Non Clinical to produce strategic development plans.

• Manage the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, budgets, and strategies.

• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.

• Participate as regulatory support on internal cross-functional initiatives.

• Provide administrative support for project management including (invoices, time and budget management, application maintenance activities and other operational activities).

• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.


Other Responsibilities:
Performs other work-related duties as assigned. Minimal travel may be required (up to 10%).


Requirements:
BS,MS or Ph.D. degree, preferably in pharmacology, toxicology, or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience. Minimum of five years’ experience.

Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, NDA, CTD (including electronic submissions), PMA, CTA, and MAA. Knowledge of regulatory guidelines and requirements and experience with nonclinical pharmacology/toxicology/pharmacokinetics strategy development, study design, data interpretation, and risk assessment. Experience working in an independent office environment. Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. Excellent written and verbal communication skills. Good quality management skills. Computer literacy in MS Word, Excel, and PowerPoint. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Good attention to detail, flexibility, and open to suggestions. 


Regulatory Manager – Non Clinical

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 23,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Summary:
Provide regulatory and nonclinical technical support for assigned product development projects, including product development documents and regulatory agency submissions to FDA, EMA, and Health Canada in CTD compliant format, and interact and collaborate with project teams on client projects.



Essential Functions:

• Author or review nonclinical sections of regulatory documents, such as investigator's brochures, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs).

• Summarize pharmacology, pharmacokinetics and toxicology data and prepare briefing packages for regulatory agency meetings or advice.

• Conduct literature search and draft safety assessments of active ingredients, impurities and excipients.

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans.

• Contribute to or prepare responses to requests for nonclinical information to worldwide health authorities.

• Assist with nonclinical pharmacology and toxicology program reviews for drugs and biologics to ensure scientific merit and regulatory compliance.

• Assist the Head of Global Regulatory Consulting Non Clinical to produce strategic development plans.

• Manage the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, budgets, and strategies.

• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.

• Participate as regulatory support on internal cross-functional initiatives.

• Provide administrative support for project management including (invoices, time and budget management, application maintenance activities and other operational activities).

• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.


Other Responsibilities:
Performs other work-related duties as assigned. Minimal travel may be required (up to 10%).


Requirements:
BS,MS or Ph.D. degree, preferably in pharmacology, toxicology, or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience. Minimum of five years’ experience.

Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, NDA, CTD (including electronic submissions), PMA, CTA, and MAA. Knowledge of regulatory guidelines and requirements and experience with nonclinical pharmacology/toxicology/pharmacokinetics strategy development, study design, data interpretation, and risk assessment. Experience working in an independent office environment. Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. Excellent written and verbal communication skills. Good quality management skills. Computer literacy in MS Word, Excel, and PowerPoint. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Good attention to detail, flexibility, and open to suggestions. 

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