Regulatory Affairs Principal
5 months ago
**The role**
We are looking for a Regulatory Affairs Principal to support our new product developments.
This role will be responsible for providing regulatory advice to our teams developing new products, and interacting with regulators and external stakeholders to ensure we gain regulatory approval in global markets. It is safe to say, this is a key role for us.
You will research regulatory requirements, prepare regulatory submissions, responses and supportive documentation, liaise with project managers, consultants and partners, and provide strategic direction around critical projects. Ideally you will have experience in all aspects of pharmaceutical development, from non-clinical to clinical and pharmaceutical chemistry. You will also ensure regulatory documentation and databases are maintained and tracked to a high standard.
**Are you ready to be a part of it?**
**What you will bring and be valued for**
You will have a minimum of 7 years of experience in pharmaceutical regulatory affairs with a focus on new product development, and Tertiary Qualification in Science or Pharmacy.
- A **REGULATORY AFFAIRS PROFESSIONAL** - you will have at least 7 years experience in pharmaceutical regulatory affairs.
- An expert **COMMUNICATOR** - you will be an open communicator. You will communicate with ease at all levels and be just as competent verbally as you will in writing.
- A **CONTINUOUS IMPROVEMENT** mindset - you have an eye for seeing where improvements can be made and how. You have strong attention to detail.
- A **COLLABORATOR** - you will like working with others, being a part of a strong team, and bringing people together to achieve goals.
You will also have strong attention to detail, problem solving and decision-making skills. You will be planned in your approach, be able to influence and have a customer focus.
**What's in it for you?**
- Flexible working options, so you can get the best out of work and life.
- THRIVE Wellbeing programme.
- Regular onsite events to celebrate our diversity.
- Five weeks leave from your sixth anniversary.
- Career growth - we relentlessly develop our people and promote internally.
- Life and income protection insurance.
- Discounted products from our consumer and nutraceutical ranges including Clinicians, BraveFace, Bio Oil, Nexcare, to name a few.
**About us**
Douglas is one of New Zealand's greatest pharmaceutical success stories with an ever-expanding footprint into global markets. We are working to develop, trial, manufacture, test, pack and distribute the very best medicines, nutraceuticals and products around the world.
At Douglas there are around 680 of us - including top scientists, researchers, manufacturers, regulators and engineers, and together we're on a mission to make high quality, effective and accessible products for people who need it.
We're helping people with conditions like depression, cancer, heart failure, severe acne and skin conditions, as well as people who need antibiotics and medicines to support their immune system.
**Next steps**
All applicants must undergo pre-employment screening and background checks.
**Legitimacy statement
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