Senior Regulatory Affairs Professional - Facility & Projects

Are you excited to be part of a dynamic and ever-evolving environment, contributing to [xxxxx]'s purpose - Drive change to defeat serious chronic diseases? Are you passionate about leading cross-product projects and eager to contribute to the launch of established and new products from our current and future manufacturing facilities worldwide? Are you driven to take on the responsibility of spearheading manufacturing facility related projects within Diabetes, Obesity, and Biotech and Rare disease (BRD) portfolios? If so, this opportunity may be an ideal match for you. We encourage you to apply now for a life-changing career. The position
As a Senior RA professional, you will be part of RA Facility & Projects team, contributing towards our primary mission to ensure efficient and predictable submissions and approvals across the globe through strategic partnerships with key stakeholders. In this role, you will take the lead in driving manufacturing facility approvals and also wide range of LCM activities for established products demonstrating a proactive approach to enhance manufacturing capacity, flexibility, and continued compliance. Key responsibilities of this role include:

To define and actively drive implementation of regulatory strategies from facilities point of view for product launch, capacity expansion, and other strategic projects going across the product portfolios.

Assume ownership for creation and maintenance of the facilities related documentation in the dossier related to facilities, equipment, and relevant processes.

Demonstrate leadership by setting strategic regulatory direction for high-impact projects, and through facilitating the regulatory approval process and health authority interactions in collaboration with Manufacturing Development, Product Supply, and affiliates.

Continuous monitoring and RA assessment of facility plans, identifying RA impact and strategies together with project teams.

Handling day-to-day tasks related to Change Requests, RA assessments, creation and handling of events, content plans etc. within our regulatory systems (such as novoGlow, Vault RIM etc.) as per global processes.

The job involves a high degree of planning, coordination, execution of tasks and projects. You will be expected to continuously update and adapt to changes in work processes. The role requires the ability to work effectively with people from different functions and organisational levels across the world, calling for high cultural awareness and the necessary skills to encourage and influence colleagues and key stakeholders. Qualifications
You come with a scientific background and mindset, acquired through your education and extensive experience in pharmaceutical operations – manufacturing, product supply, CMC process development, quality assurance, and other related areas. To be successful in this role, you should have:

University degree in Pharmaceutical Engineering, Life Sciences, or similar field of study.

At least 5 years of relevant experience within the pharmaceutical industry.

Strong GMP knowledge with a proven track record of driving regulatory strategies for approval of new/revamped manufacturing facilities.

Proven skills within Project Management.

Hands-on experience navigating within an environment of tight timelines, high complexity, non-standard and diverse tasks, and a broad stakeholder landscape.

Being a contributing team player and enjoy working with people from diverse backgrounds.

On a personal level you are pro-active and positive with can-do attitude. You do possess excellent communication and collaboration skills, which are fundamental in this role for effective interaction with others. You are self-motivated which signifies an internal drive and initiative to accomplish tasks both independently and collaboratively within a team setting. Finally, you have a strong attention to detail and the ability to work in a fast-paced environment. Fluency in English, encompassing both verbal and written communication, is essential for effective engagement and collaboration with various stakeholders. About the Department
RA Facility & Projects is a part of the Submission Excellence area within RA CMC & Device. RA CMC & Device is one of the two headquarter-based regulatory functions with responsibility to drive regulatory strategies for projects from the early phases of development and throughout during the LCM phases of marketed products worldwide. RA Facility & Projects team consists of scientific profiles with an extensive regulatory experience, along with strong project management and coordination skills. We work in close collaboration with departments across RA CMC & Device, as submission responsibility and overall product accountability lies with them. We are a team of 8 passionate, talented, and diverse colleagues from 4 different cultural backgrounds. We embody the NNway serving as role models, taking care of each other, and creating a thriving and happy work environment. Employee well-being is our top priority. Working at [xxxxx]
[xxxxx] is its people. At [xxxxx], we don’t wait for change. We drive the change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. We offer a competitive salary and benefits package, as well as opportunities for growth and development within our organization. Contact
For further information regarding the position, please contact Srinivasulu Reddy Mule (Srini) at +[xxxxx]. Deadline
09 June 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.