Regulatory Strategist

Syneos Health; California (MO); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Syneos Health is seeking a Regulatory Strategist to lead LATAM regulatory activities, including submissions and lifecycle management, while collaborating with Global Regulatory Affairs to ensure best practices. The role requires strong cross-functional interaction and local regulatory expertise.

Ideal candidates will have Latin America regulatory experience, be able to interact with authorities, and possess a Pharm Sciences degree with English plus Spanish/Portuguese as an advantage.

Qualifications

• Relevant regulatory affairs experience in Latin America.
• Experience of interacting with Regulatory Authorities.
• Bachelor’s degree in Pharmaceutical Sciences; English plus Spanish/Portuguese advantageous.

Responsibilities

• Lead regulatory strategy and local activities in Latin America for MAAs and lifecycle management.
• Track Health Authority requests and new local regulations and inform GRA teams.
• Prepare submission timelines and binders in Veeva and ensure up-to-date files.
• Coordinate cross-functional teams to prepare submissions from planning to review.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional

Education

Bachelor’s degree in Pharmaceutical Sciences

Tools

Veeva

Job description

Regulatory Strategist Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work for. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities International - Reg Strategy Manager, Sr Manager (LATAM)

The Regulatory Affairs Manager will be lead and support submissions in Latin American Markets for MAAs and life-cycle management procedures and will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.

• Drive and coordinate regulatory strategy and local regulatory activities in Latin America and provide regional regulatory expertise for geographical expansion.
• Track all Health Authorities’ requests and relevant new local regulations and forward to relevant GRA contact.
• Maintain current knowledge of local requirements and anticipate, assess and communicate changes to Regulatory Senior Management in a timely manner.
• Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date.
• Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner.
• Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as regulatory requirements, local labelling guidance, CTD and GMPs.
• Ensure all work is compliant with regulatory requirements and company policies and procedures.

Regulatory Experience & Education Requirements

• Relevant industry experience in regulatory affairs in Latin America and understanding of current trends in local and regional requirements.
• Recognized as a knowledgeable resource for regulatory advice by other departments.
• Experience of interacting with Regulatory Authorities.
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners).
• Bachelor’s degree in Pharmaceutical Sciences advanced written and spoken English and knowledge of Spanish and Portuguese will be considered an advantage.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.