Regulatory Affairs Manager

Full time based Weybridge Surrey with flexible working

Core Competencies

  • Self-starter

  • Strategic thinker and planner

  • Decision maker

  • Persuasive, Influential

  • Gets stuff done

  • Strong business and commercial acumen

  • Articulate, good communicator

  • Innovative

  • Challenges the status quo – always better

  • Ability to multi task & project manage

  • Collaborative Team player

 

 

Key Responsibilities

  1. Provide regulatory leadership, governance, compliance and expertise to the Maxwellia portfolio such that new innovative products are successfully re-classified, introduced and maintained in the relevant territories.

  2. Prepare and submit regulatory documentation in accordance with the project plan and key milestones.

  3. Ensure compliance with pharmacovigilance and quality obligations in collaboration with external service providers.

  4. Be a pivotal member of the Rx to OTC switch team developing Maxwellia as a centre of excellence in Rx to OTC switch for Maxwellia in UK and further territories as the business plan determines.

  5. Build a network of collaborative relationships within the company and with external service providers to ensure all regulatory requirements are met for existing and new products according to Maxwellia values.

  6. Ensure promotional materials and campaigns follow brand guidelines, local regulations and compliance standards.

  7. Be a self care champion

 

The Role - Regulatory Affairs Manager

  1. Provide regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices development, re-classification and regulatory requirements as appropriate.

  2. Develop novel regulatory strategies and influence approaches within Project Teams to secure competitive approvals and speed to market.

  3. Take a lead role in the interactions with MHRA and IMB (EMA and other regulatory authorities) and develop key contacts.

  4. Communicate effectively within the function at all levels and within multi- disciplinary project team.

  5. Plan, prepare and deliver high quality core dossiers to agreed timelines such as new MAAs, re-classification applications, and other documentation related to the maintenance of existing MAs such as renewals, safety submissions, variations, labelling changes etc. and be responsible for the submissions of CTAs to relevant regulatory authorities via a third party agency.

  6. Prepare and update national Product Information in accordance with European templates and requirements of the national authorities

  7. Ensure compliance with pharmacovigilance and quality obligations including the development and maintenance of standard operating procedures and the Quality Systems Manual.

  8. Creation and assessment of internal quality and non-quality changes in line with the change control management system

  9. Artwork review and approvals (PIL, primary and secondary packaging), including preparation of User Test Bridging Reports for the approval of leaflet changes.

  10. Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the Maxwellia Project Team.

  11. Support the full life cycle of products, including: maintenance activities; complexity reduction, engineering initiatives; change controls, Core File updates.

  12. Ensure compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.

  13. Interpret and apply all relevant legislation in the UK and EU to keep the Maxwellia business up to date on national regulatory trends, risks and opportunities.

 

Personal Profile

  • Degree in a pharmaceutical or life science plus regulatory experience

  • Thorough understanding of the current UK and European regulations, laws, guidelines and industry requirements.

  • Proven record of developing regulatory strategies - experience of:

    • UK/Irish/EU

    • Medicinal (essential), cosmetic or medical device regulations

    • significant adjacent experience in NPD, Quality, Medical, Toxicology within a Consumer Healthcare environment

  • Experience of DCP and/or MR procedure

  • Familiarity with relevant software related to regulatory activities

  • Exceptional ability to manage workload and identify priority tasks to meet tight deadlines

  • High level communication skills verbal and written

  • Insightful and forward looking; strategic thinker

  • High level of business maturity

  • Proficient in Microsoft Windows applications, including Word, Outlook and PowerPoint

  • Passionate about” self care”

  • An interest in health technology

  • Lives within commuting distance of Weybridge, Surrey.

Benefits

Competitive salary up to £60,000 Pension + Private Healthcare

Employee Management (Share Options) Incentive Scheme (subject to length of service criteria)

Flexible working

The company will invest in relevant training and ongoing CPD.

 

To Apply

Please send CV to anna@maxwellia.com with 3 reasons why you think you are the right person for this opportunity.
 

+44 (0)1932 450102

Block 20, Alderley Park, Alderley Edge, SK10 4TG

©2018 by Maxwellia