Regulatory Affairs Consultant
4 days ago
Syneos Health is a global contract research organization (CRO) providing a complete range of services to support all phases of drug development. We leverage a network of thousands of experienced professionals and a dynamic global footprint to deliver innovative solutions tailored to meet our clients' needs. Our approach combines a rich heritage of scientific expertise with cutting-edge technology and exceptional collaboration to ensure accurate, timely, and cost-effective delivery of results.
Your Role
As a Sr Regulatory Consultant, you will play a vital role in supporting the growth and success of Syneos Health's regulatory department. This includes ensuring that all regulatory submissions are completed accurately and efficiently, interacting with various stakeholders to discuss and resolve any issues related to regulatory matters, and maintaining up-to-date knowledge of regulations, guidelines, and best practices in the biopharmaceutical industry.
Responsibilities
- Evaluate and interpret relevant regulations, guidelines, and policies to inform strategic decisions.
- Collaborate with cross-functional teams to identify and mitigate potential regulatory risks associated with new products, projects, or business initiatives.
- Lead the development of comprehensive regulatory strategies and plans to align with business objectives.
- Ensure compliance with regulatory requirements, laws, and policies governing the conduct of clinical trials, product submissions, and labeling.
- Communicate complex information effectively to various stakeholders, both internally and externally, including regulatory agencies, sponsors, and investigators.
- Maintain and expand relationships with regulatory agencies, healthcare professionals, and professional associations to stay informed about emerging trends and regulatory developments.
- Provide subject matter expertise to support business development opportunities, client interactions, and R&D activities.
- Support training and mentoring programs for junior colleagues to enhance their regulatory knowledge and skills.
Requirements
The ideal candidate will have a Bachelor's degree in a life sciences or related field, or equivalent experience. A Ph.D. is preferred but not required. In addition to academic qualifications, the following skills and qualities are necessary:
- Proven expertise in regulatory affairs with a deep understanding of ICH GCP, FDA 21 CFR Part 11, and EU GDP regulations.
- Strong analytical, problem-solving, and communication skills with the ability to negotiate and influence various stakeholders.
- Excellent organizational and time management skills to prioritize tasks effectively and manage multiple projects simultaneously.
- Ability to work independently, think critically, and make sound judgments while staying adaptable to changing priorities and deadlines.
- A strong passion for continuous learning and staying current with the latest regulatory developments and best practices in the industry.
What We Offer
At Syneos Health, we offer a competitive compensation package, benefits, and opportunities for growth and development. Our team members enjoy a collaborative and inclusive work environment, flexible working arrangements, and a commitment to employee well-being and safety.
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