Regulatory Affairs Manager
- Experience Level
My client are a global pharmaceutical company that develops & markets innovative medicines for patients with life-threatening conditions. They are well-financed and have significant resources committed from our equity sponsors for tack-on deals and larger transaction opportunities. This company are accelerating their global expansion and establishing new therapeutic franchises, evolving as a leader in providing highly efficacious therapeutic solutions to patients at affordable prices.
If you are looking to be a part of a dynamic, global, fast-growing organisation, have a positive attitude, willing to develop yourself, and are energised by being a part of improving the health of others, we are the perfect match for you. By joining us as the Regulatory Affairs Manager you will interact with all departments and actively build the future of the company.
IN THIS ROLE YOU WILL:
- Coordinate, prepare or review regulatory submissions for all projects to include but not limited to new MAAs, variations and other associated life cycle maintenance submissions.
- Manage and facilitate all life cycle maintenance activities with partner CROs
- Review change controls for the regulatory team
- Help with regulatory related questions and complaints
- Lead the artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging
- Review labelling (SPC, PIL and Labelling) for compliance against current EU guidelines and standards
- Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved effectively and on time.
- Maintain relationships with print suppliers and the artwork studio
- Coordinate review & approval of EU promotional material
- Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
- Follow company policies and procedures
- Collaborate with team to establish and meet targets and timelines
- Help generate SOPs and Work instructions
- Identify, design and implement process and system improvements
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