CAIA's Career Center is an easy-to-use, comprehensive resource connecting job seekers with employers in the growing AI field. Use your knowledge and credibility to advance your career or build a talented team for your organization. Opportunities targeted to CAIA Charterholders are prioritized.
In order to search for jobs specifically for CAIA Charterholders or those pursuing the CAIA Charter please enter “CAIA” in the search panel.
This will enable you to search for CAIA specific roles globally.
The Pharma Technical Operations Regulatory (PTR) International Operations Manager position is responsible for the execution of regulatory CMC submissions for all Roche products through developing and implementing robust end to end strategies of the local filings. This based on global development plan, global/regional/local business priorities, local regulatory requirements and landscape to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Health Authorities. In this role you will act as subject matter expert in LATAM CMC regulatory requirements for submissions globally and assure maintenance of regulatory requirements for LATAM markets. You will defend cases where limited data is available and ensure that authorities can understand the product need in the respective country. Your further responsibilities and accountabilities include:
Serve as the International Technical Regulatory Partner for development/marketed product team who is a single point of contact for topics and issues relating to international submissions for a product
Development of innovative regulatory strategies across Roche Pharma Portfolio and throughout the products lifecycle
Ensuring up-to-date LATAM requirements are maintained, communicated and integrated into project teams work plans
Ensure alignment and regulatory stakeholder engagement with project teams, PDR ERAS Team and Regulatory Policy Group
Act as PTR (CMC) expert for International Markets filings who through partnering with global Pharma Technical Regulatory (PTR) Teams, develops and executes regulatory filing strategies for initial marketing applications and life cycle management submissions toward maximizing efficiency, quality and rate of submission approvals by Health Authorities
Liaise with Regional Supply Chain, Quality, and Affiliates DRA for development and execution of PT strategy roadmap, maximizing and balancing regulatory and supply needs in the region and enabling, prioritization of change management activities
In collaboration with internal partners (PDR ERAS), develop and execute objectives and plans toward aligning one global regulatory voice/outlook to affiliates and Health Authorities in the LATAM region
Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility and support tracking of CMC commitments with regional Health Authorities in regional markets under responsibility
Who you are As the ideal candidate for the role you have a Bachelor's degree in life sciences, pharmacy or biotech manufacturing. A further degree (Master, Post Graduate or MBA) is strongly preferred. You were able to gain 8-10 years of working experience in the pharmaceutical industry and bring exposure to and strong understanding of the LATAM regulatory environment. You need to have proven experience in presenting strategies for a given product to LATAM Health Authorities. You possess the ability to navigate in a complex matrix organization, collaborate, engage and influence decision-making without formal authority Your further qualification and skills:
Deep knowledge of ICH and cGMPs, global regulations and health authority guidance
Strong proven experience in Regulatory Affairs with focus on CMC requirements for biologic products, development, manufacturing and/or quality assurance experience is a must. Similar knowledge in small molecules is a plus
Demonstrate effective problem-solving ability, strong understanding of regulatory strategies, excellent interpersonal skills and ability to prioritize multiple tasks
Great team player with high level of professionalism and continuous improvement mindset
Fluency in English as well as Spanish written and spoken is a must. Knowledge of Portuguese is a plus
Travel requirements: Ability to travel up to 25% and willingness to work across multiple time zones. Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
If you have questions then please check our FAQs and videos on careers.roche.ch/faq.
Wer wir sind At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.