Regulatory Affairs Manager
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Regulatory Managers play an important role in executing regulatory outsourcing projects for global clients. The role may lead or be a member of high-performing teams of typically 3-8 people on challenging assignments involving the processing of regulatory information. Regulatory activities will be undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.
- Be a part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for Global clients.
- May be responsible for managing project deliverables in line with the project plan.
- May have oversight of initiation, execution and completion of projects for clients and ensuring delivery is within time and budget; if not, take corrective action.
- Perform content technical review of work by other team members on an ongoing basis.
- Act as a subject matter expert and help the team members with day-to-day trouble shooting activities.
- Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
- Keep a vigilant eye on changing processes in industry and suggests areas for improvement in internal processes along with possible solutions.
- Communicates effectively with internal clients to identify needs and evaluate alternative business solutions.
- A minimum of a graduate degree in Life Sciences.
- Experience in Regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical company is preferred.
- Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
- May be an experienced people manager.
- Significant knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
- Ability to motivate team members, provide coaching and support development, troubleshooting, tracking deadlines and acting as a primary or second degree reviewer.
- Excellent written communication skills.
- Working knowledge of basic computer applications, e.g. MS Word/PowerPoint/Excel.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.