At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Where do you want to go?
In our consumer health division we aim to empower the transformation of everyday health. Our innovation capabilities and relentless pursuit for sustainability compel us to drive positive change for people and our planet.
Do something that moves you.
- Be responsible for all regulatory affairs activities of assigned portfolio including maintenance and development of all product activities dealing with the relevant Health Authorities and Government bodies
- Maintain full awareness of all regulatory activities, whist working closely with a wide variety of internal stakeholders to ensure project deadlines, performance and compliance standards for portfolio are established
- Work independently towards best practice regulatory planning and preparation for all new product applications, new chemical/biological entities (NCE/NBEs), new indications and line extensions to be registered in the best possible time frame and with the best possible label
- Act as primary liaison to the national health authority and other national regulatory agencies. Facilitates effective communication between functional areas and their counterparts at the regulatory agencies if required.
- Build, maintain and strengthen rapport with the national health authority and other relevant national regulatory agencies
- Ensure proper maintenance and updates of product licenses in compliance with global standard and local regulations
- Review and approve packaging text to ensure compliance with registration and legal requirements
- Maintain global regulatory databases as per SOPs: approvals, documentation, correspondences filing in CARA and local dossier archives
- Identify current and emerging regulations which impact product development and / or marketing processes and collaborates with the business to realise commercial outcomes
- Partner with the Quality team to complete GMP requirements including GMP applications and certifications of the manufacturing sites as locally relevant
Does this sound like you?
- Degree in Science or equivalent scientific degree
- Direct industry experience ideally spanning across full development spectrum (early/late/post-market)
- Proven track of managing complex regulatory applications to successful outcomes
- Consumer Health, FMCG, Food and Chemicals industry experience highly regarded
- Ability to understand a wide range of complex regulations and apply them
- Strategic thinker who can evaluate complex/ambiguous situations
- Demonstrated ability to create and foster collaborative relationships within a team environment
- Demonstrates excellent judgement, problem solving, verbal and written skills to effectively communicate and influence internal and external stakeholders
- Comfortable working in fast paced environments with changing priorities, robust processes and delivery timelines
Be You @ Bayer
We are committed to creating a culture where people can be their best, in an environment that values inclusion, diversity and flexibility. At Bayer everyone belongs, regardless of race, colour, ancestry, religion, national origin, citizenship, sexual orientation, age, marital status, disability, or gender identity. We encourage Aboriginal and Torres Strait Islander people to apply. We also welcome applicants with diverse educational backgrounds, professional knowledge, personality types, thinking styles and life experiences. If you have a disability or special need that requires accommodation, please let us know.
Be part of something bigger
At Bayer we support your career. Ready to join our team? Click Apply. For more information about this role and the innovative suite of benefits on offer, get in contact with our Talent Acquisition Team via jobs.anz@bayer.com . We look forward to hearing from you.
Recruitment agencies please note that this position will be managed via our in-house Talent Acquisition Team. Bayer does not accept any unsolicited resumes.