The Position

Join our powerful team and help Roche bring new medicines to the patients! As Technical Regulatory at Roche, we have a key role in the process of developing new medicines and making them available to patients worldwide.

Job Mission

We provide the strategy, expertise and guidance to ensure world-class technical regulatory support for the chemistry, manufacturing and controls (CMC) section of clinical trial licensure applications, new market applications, and post-approval changes. We also develop and implement filing strategies, deliver CMC dossiers, provide expertise as members of development teams, collaborate with health authorities and industry groups all over the world, and support quality systems.

The International Operations team is looking for a passionate Technical Regulatory Affairs Manager who is ready to use their own experience and expertise while being curious about learning new skills and ready to explore known and new regulatory fields.

Your Impact

• In coordination with the global Pharma Technical Regulatory (PTR) Teams, developing and executing regulatory filing strategy for initial marketing applications and CMC changes originating at manufacturing sites globally toward maximizing efficiency, quality and rate of submission approvals by Health Authorities
• Liaising with Regional Supply Chain, Quality, and Affiliates DRA for the development and execution of a regional PT strategy roadmap, maximizing and balancing regulatory and supply needs in the region and enabling, prioritization of change management activities
• Acting as subject matter expert in CMC regulatory requirements for all submissions and assuring maintenance of requirements for regional markets under the responsibility
• Handling timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under the responsibility and supporting tracking of CMC commitments with regional Health Authorities
• Developing and executing objectives and plans toward aligning one global regulatory voice/outlook to affiliates in the region in collaboration with Pharma Development Regulatory - Emerging Markets & Regional Affiliates Support (PDR - ERAS)
• Mentoring/coaching other members of the International Operations group
• Supporting or leading departmental operational excellence and business process initiatives

Who You Are

You hold a Bachelor of Science or higher degree (e.g. in Analytical Biochemistry, Biology, Pharmacy, or similar) .

You are confident in working and can work effectively in a global matrix environment and have the ability to build trusted relationships worldwide. You gathered ideally 5 years of experience in the pharmaceutical area.

Experience in Regulatory Affairs with a focus on CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance and/or experience in international markets or having diverse background and expertise in regulatory digital solutions in the pharmaceutical industry or Cell and Gene Therapies - would be a plus.

While You are ideally someone who has

• Strong knowledge of ICH and cGMPs, global regulations and health authority guidance
• Proven effective problem-solving, strong understanding of regulatory strategies, excellent interpersonal skills and the ability to prioritise multiple tasks
• Passion for regulatory and enthusiasm to explore opportunities to learn, grow, and influence the regulatory landscape internally and externally
• High interest in continuous improvement, bringing the attitude and behaviours to drive such initiatives through the use and application of LPS (lean production system) tools
• The understanding of the concept and ability to work efficiently in a diverse self-managed team
• The capability to create and maintain a positive, collaborative and productive working environment
• Fluency in English and must have a proven ability to communicate effectively in both a written and verbal format

Travel requirements: approx. 10%

Who we are

At Roche, more than 100,000 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.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.