Regulatory Affairs Manager
- Regulatory Affairs
Competitive Salary and Benefits Scheme
Regulatory Professionals are currently collaborating with an exciting business based in North East Hampshire, whose focus is within the research, development and commercialisation of ophthalmic pharmaceuticals. Based on a well-developed business park with modern offices and an excellent working environment, this is a fantastic opportunity for a Regulatory Manager to broaden their skill set, take on new learning and develop effective working relationships
Role Requirements though not limited to:
To plan, prepare and submit regulatory submissions
Contribute to policies in regulatory and quality affairs, and ensure standards are established and complied with.
Planning, preparing and filing of regulatory submissions for marketing authorisations, variations, supplements, promotional materials, risk minimisation materials and other regulatory submissions as required by the business
Manage operational aspects of Regulatory filings with partners in international regions e.g. Middle East, Australia, Canada, USA.
Act as internal consultant for labelling/packaging, artwork for commercial portfolio across the regions. Developing national texts (PI, PIL, SPC, packaging) including coordination of translations.
Collaborate with clinical team to prepare CTAs and other clinical documents where appropriate.
Represent the company in interactions with regulatory authorities as appropriate.
Minimum: Degree in life sciences / pharmacy or higher
Experience in preparing submissions and life-cycle management
Experience in authoring regulatory documents and quality documentation and ideally experience in training to support implementation.
Broad knowledge of European regulatory systems. Knowledge of relevant current and upcoming legislation.
If you are interested in discussing this role further then please email your CV to firstname.lastname@example.org or call Kirsty on 01189 522 979 to arrange a confidential discussion.