Mgr, Regulatory Consulting

2+ years

$71,820 - $139,600 annually

Remote, USA

10 Sept. 23, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market challenges. Our Clinical Development model centers on customers and patients, striving to simplify and streamline our processes for improved collaboration.

Join our passionate team of problem solvers, and help us innovate to achieve our clients’ goals. With a global workforce of 29,000 across 110 countries, we believe that WORK HERE MATTERS EVERYWHERE.

Why Choose Syneos Health?

We are committed to the growth and development of our employees through:

Career progression opportunities
Supportive management and mentorship
Comprehensive technical and therapeutic training
Peer recognition and a robust rewards program

Our Total Self culture encourages authenticity and unites us globally, fostering a workplace where diversity of thought and background is celebrated.

Key Responsibilities

Lead planning for regulatory submissions in assigned regions/countries/projects.
Manage day-to-day operations of project teams and oversee project execution.
Supervise staff, handling recruitment, performance management, coaching, and employee development.
Serve as a liaison between the regulatory department and other departments.
Support business development by nurturing client relationships and developing proposals.
Monitor and manage project budgets, client invoicing, and resource utilization.
Act as the primary contact for clients and regulatory authorities, providing strategic regulatory advice.
Conduct regulatory research and prepare submissions (e.g., IND, PMA, NDA, MAA, CTD).
Organize and lead meetings with clients and regulatory agencies, reporting outcomes.
Contribute to the development of regulatory systems and quality improvement initiatives.
Enhance the company’s reputation as a regulatory leader through industry participation, including speaking engagements and publications.

Qualifications

Bachelor’s degree in a science-related field or equivalent experience in regulatory, medical writing, or pharmaceutical/medical device industries.
Moderate experience in regulatory submissions (IND, PMA, NDA, MAA, CTD) with knowledge of niche submissions (e.g., ODD, PIP/PMP) preferred.
Strong understanding of pharmaceutical or medical device product development and regulatory landscapes.
Excellent written and verbal communication skills, coupled with exceptional customer service abilities.
Proficiency in project management, problem-solving, and decision-making.
Advanced skills in Microsoft Office Applications.
Strong analytical skills with meticulous attention to detail.
Ability to manage multiple projects with diverse instructions.
Fluent in English (reading, writing, speaking).

Get to Know Syneos Health

In the last five years, we have collaborated on 94% of all novel FDA-approved drugs and 95% of EMA authorized products, conducting over 200 studies across 73,000 sites involving more than 675,000 trial patients. Every role contributes to our mission to challenge the status quo in a dynamic environment.

Additional Information

This job description is not exhaustive; Syneos Health may assign additional tasks as needed. We value equivalent experience and qualifications and will determine suitability based on various factors.

Syneos Health promotes a voluntary COVID-19 vaccination policy and encourages employees to get vaccinated. Compliance with local government or client requirements may also apply.

We believe in creating a diverse, inclusive workplace that allows our people to thrive. Our benefits package may include:

Company car or car allowance
Health benefits (Medical, Dental, Vision)
401(k) matching
Employee Stock Purchase Plan eligibility
Performance-based commissions/bonuses
Flexible paid time off and sick leave

Salary Range: $71,820 - $139,600 annually, based on qualifications and experience.

Apply for This Role

Not ready to apply? Join our Talent Network to stay connected for future opportunities. At Syneos Health, we welcome diverse experiences and encourage you to apply even if your background doesn't perfectly match the job description.

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Mgr, Regulatory Consulting

Job Description

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