Director of Regulatory Affairs

4 weeks ago

London Area, United Kingdom CNX Therapeutics Full time

Job title: Director of Regulatory Affairs

Department: Scientific Affairs

CNX Therapeutics is a European pharmaceutical company dedicated to improving the lives of patients through the supply of essential medicines. We commercialise and distribute a portfolio of speciality brands and hospital products in Europe, in 40 countries worldwide, both directly and through strategic partnerships. Our vision is to become a recognised partner of choice through our commercial excellence, patient focus and presence across Europe.

We want to be Pioneers We may be small, but we’ve got some big goals. That’s why, at CNX, ESG (Environmental, Social, and Governance) isn’t just a fancy acronym; it’s a roadmap to our future success. Why, you ask? Well, it’s because we want the work we do to have a positive impact, on ourselves, on each other, on the world we live in and on the patients we serve.

And guess what? It’s on all of us to do this. So, whether you’re crunching numbers, selling products, moving those products around, maintaining our high ethical standards, or brainstorming new ideas, remember that every small action counts. CNX will do its bit for you through our inclusive and family-friendly benefits and ways of working, supporting your professional and personal growth, so you are empowered to pay it forward every day.

The Role

The Head of Regulatory Affairs will play a crucial role in ensuring compliance with regulatory requirements and guiding the registration, and commercialization of pharmaceutical products. This position involves overseeing a team of regulatory professionals, collaborating with cross-functional teams, and liaising with regulatory authorities to secure and maintain product approvals.

Create and manage the global Regulatory strategy for the CNX business and ensure alignment with business growth and commercial strategy.

Support and coordinate activities with partners and contract Regulatory Affairs providers for all CNX products.

Ensure CNX is compliant with global Regulatory legislation at all times.

Live the CNX Values. Maintain high standards of ethics and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG).

Regulatory Strategy Development:

Formulate and execute regulatory strategies to support the registration and lifecycle management of pharmaceutical products in line with company expectations and required timelines. Keep abreast of global regulatory trends and changes, assessing their impact on the company's regulatory activities.

Team Leadership and Management:

Lead and manage a team of regulatory professionals, providing guidance, mentoring, and ensuring the team's continued professional development. Foster a collaborative and innovative regulatory culture within the organization.

Regulatory Submissions:

Oversee the preparation, submission, and maintenance of regulatory filings, including Marketing Authorization Application (MAA), and variations/supplements. Ensure submissions are accurate, complete, and in compliance with regulatory requirements.

Due Diligence:

Lead regulatory due diligence activities, particularly acquisitions of new products / companies. Be the regulatory representative for projects and manage regulatory project actions. Support technical transfer projects via Technical Project Manager.

Interaction with Regulatory Authorities:

Establish and maintain strong relationships with regulatory agencies, representing the company in meetings, consultations, and negotiations. Proactively seek advice from and respond to regulatory queries and requests in a timely and effective manner.

Cross-Functional Collaboration:

Collaborate with cross-functional teams, including Corporate Development, QA, PV&MI, Technical, Supply Chain, Commercial Operations etc. to align regulatory strategies with overall business goals. Provide regulatory guidance to project teams and contribute to decision-making processes.

Regulatory Compliance:

Monitor and ensure ongoing compliance with regulatory requirements throughout the product lifecycle. Implement strategies to address regulatory issues and challenges promptly. Ensure regulatory affairs files are always maintained to support compliance with regulatory requirements.

Regulatory Intelligence:

Stay informed about changes in regulatory requirements and industry best practices, providing proactive advice to the organization on potential impacts and insights to support strategic projects and products.

Risk Management:

Identify and assess regulatory risks, proposing mitigation strategies to minimize potential impact on regulatory submissions and approvals.

Other Responsibilities:

Accountability for regulatory strategy and delivery of projects and activities on time in a fast growing environment.

To proactively provide regular updates to relevant internal stakeholders to ensure high visibility of the status of regulatory affairs activities.

Fully embrace CNX’s culture and to serve as a role model for colleagues by operating in a mature and professional manner and consistently demonstrating CNX’s core values.

Author, review and revise CNX SOPs, policies, work instructions etc., relevant to the setup, maintenance and operation of Regulatory Affairs in line with country, regional or global legislation.

Support internal and external audits by Health Authorities regulatory agencies, suppliers, and partners as required.

To effectively manage multiple tasks, and workstreams in an efficient way whilst always demonstrating a high attention to detail.

Ensures compliance with the General Data Protection regulation (EU 2016/679 (GDPR)) in relation to processing of Personal Data at all times within the responsibilities of this role.

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