Regulatory Strategist

reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization reputed company, helping them reputed company complexity, anticipate change and accelerate reputed company.

Our reputed company Solutions team members reputed company with a drug development reputed company, 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 reputed company to help our customers reputed company their goals. We are reputed company and driven to reputed company – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 reputed company colleagues already know:

Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company 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 reputed company – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the reputed company of reputed company reputed company.

Job Responsibilities

International – Reg reputed company Manager, Sr Manager (reputed company)

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

Key Duties & Responsibilities

• reputed company and coordinate regulatory reputed company and local regulatory activities in Latin America and reputed company regional regulatory expertise for geographical expansion.
• reputed company reputed company Health Authorities’ requests and relevant new local regulations and reputed company to relevant GRA contact.
• Maintain reputed company knowledge of local requirements and anticipate, assess and communicate changes to Regulatory Senior Management in a reputed company manner.
• reputed company cross functional reputed company team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• reputed company as support to submission reputed company by preparing timelines and creating submission binders in reputed company and ensuring submission and correspondence files are up to date
• reputed company local regulatory expertise, maintain reputed company knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a reputed company manner
• reputed company 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 reputed company 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 reputed company 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 reputed company to facilitate interactions with International Regulatory Affairs, other departments reputed company reputed company and reputed company 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 reputed company

Get to know reputed company

Over the past 5 years, we have worked with 94% of reputed company 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 reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.

Additional Information

Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed 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 reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company 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 reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.

Originally posted on Himalayas