Regulatory Affairs Consultant (remote-based)

Hobson Prior is currently seeking a Regulatory Affairs Consultant for one of the world's largest healthcare companies. This client aims to improve access and affordability to pharmaceuticals enabling healthier communities worldwide. This role will be mix of office and remote based.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Supports the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfolio range.
• Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
• Responsible for regulatory activities related to National and/or European procedures as appropriate.
• Define regulatory strategies (local and regional) in line with business plan.
• Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
• Prepares and compiles regulatory submissions , responses to Regulatory Agency questions and other correspondence in accordance with EU & UK regulations and guidelines.
• Sign off packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance for submissions.
• Ensure Marketing Authorisations are maintained and renewed, and sunset obligations are met.
• Ensures compliance within the department by ensuring.
• Global, EAME and local databases are fully maintained.
• Processes, SOPs, working instructions and Job Aids are adhered to.
• Update relevant local and global databases to track current product information.
• Receive and monitor responses to Calls for Information through liaison with UK and EAME colleagues.
• Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the department and functional policy.
• Provide support with responses to ad hoc requests received from UK PV group or Global functions.
• Ensure RA obligations are met in line distributor agreements with third parties (as appropriate).
• Maintain awareness/knowledge of current regulatory guidance and legislation, in particular related to Brexit.

Requirements:

• Complete induction programme in line within the defined timelines.
• Develop product and therapeutic area knowledge as needed.
• Ensure that any processes or SOPs/working instructions/ job aids roll outs are actioned in Compliance Wire and within the defined timeline.
• Maintains training record.
• Life sciences or chemistry graduate to honours level or equivalent.
• Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience.
• Brexit related regulatory knowledge and experience.
• Must have hands on experience in management of day to day UK and EU regulatory procedures.
• Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.