Regulatory Affairs Manager; CMC)

Our client is a private pharmaceutical company specialising in the development of products that meet the needs of Patients, Healthcare Professionals and Healthcare Systems. They are rapidly growing and have an exciting portfolio of products in development.

As part of their growth they are looking for a Regulatory Affairs Manager (CMC) to lead on their UK regulatory strategy and to manage relationships with third party developers.

They are located in Weybridge in Surrey and require on site visits at least 3 days a week.

The Regulatory Affairs Manager - CMC
, reporting to the Scientific Affairs Director, supports the regulatory team and will provide strategic direction to ensure compliance with applicable laws, regulations, and standards. This role involves working closely with cross-functional teams, including research and development, regulatory affairs, quality assurance, and marketing, to ensure alignment with scientific and regulatory objectives. The Regulatory Affairs Manager will foster key relationships with relevant outsourced providers such as CDMOs to ensure true partnership working, using highly efficient project management skills.

• Regulatory Compliance and Activity:
• Collaborate with regulatory affairs team to ensure compliance with applicable medicines regulations and standards.
• Support the preparation of submission of regulatory documents, in particular module 3.

• Control of artwork for medicinal products, including approval of artwork, interaction with external graphic designer.
• Review of batch manufacturing and batch packaging records to ensure alignment with the dossier.
• Gathering manufacturing documentation and preparation of the dossier for submissions
• Leading on response to regulatory authorities, in particular with regards to module 3.
• Provide true regulatory expertise and project management skills, especially in the area of CMC.

• Third Party Management:
• Develop comprehensive relationships with outsourced development partners to ensure they provide all of the relevant information needed for dossier submission in a timely manner.
• Proactively manage these partners to ensure they prioritise Penlan projects to minimise delays to regulatory milestones and launch.
• Clinical Research and Development:
• An ability to take projects in early development and drive them through to launch, moving seamlessly through regulatory milestones and submissions.
• Other
  
  Key Responsibilities:
• To maintain an awareness of, and compliance with the company Quality policy.
• Provide guidance and support to team members in their professional growth and
• Develop and deliver training programs to internal stakeholders on regulatory matters.

• Assess and mitigate risks associated with scientific and regulatory matters, proactively identifying potential issues and implementing appropriate measures to ensure compliance and patient safety.

• 5+ years' experience leading in regulatory CMC activities.
• Experience managing development projects with 3rd party organisations and proven expertise at understanding what data is needed to gather it for dossier submission.
• A strong sense and ability to prioritise activity to minimise delays during the regulatory process.
• A very high level of CMC working knowledge.
• Proven track record of successful interactions with regulatory authorities and/or industry stakeholders.
• Highly proficient on Microsoft Excel, Word, and IT systems in general.