Manager, Regulatory Registration and Compliance

The Manager Regulatory Registration and Compliance is responsible for developing the strategy based on regulatory requirements and for preparing/reviewing relevant Project Plans joint operating procedures and/or templates. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. This role also provides strategic regulatory guidance training coaching and mentoring to junior members; may be required to line manage members of staff.

• Lead and coordinate complex regulatory projects ensuring timely high-quality delivery and compliance with regulatory requirements.
• Develop regulatory strategies manage project setup activities and provide expert guidance to internal and external stakeholders.
• Prepare review and oversee regulatory submissions and documentation for FDA EMA and other health authorities.
• Identify and mitigate risks resolve project issues and ensure adherence to company processes and standards.
• Manage project resources budgets and team performance to meet agreed timelines and objectives.
• Support business development through proposal development budgeting and client engagements.
• Mentor and coach junior team members to support their development.
• Build and maintain strong relationships with clients partners and internal stakeholders.
• Monitor regulatory intelligence and communicate relevant regulatory and legislative updates.
• Support client qualification audit and inspection readiness and responses to findings.
• Oversee vendor qualification and performance ensuring compliance with company standards.
• Drive process improvements and lead departmental and organizational change initiatives.

Qualifications :

• University education in Natural Sciences Chemistry Medicine Pharmacy or Pharmacology
• Experience in the pharmaceutical CRO or regulatory sector including experience in a leadership or project management role
• Knowledge of Regulatory (EU) area and applicable legal and other requirements both local and global within pharmaceutical industry (knowledge of ICH GCP/GVP and applicable regulatory requirements)
• Excellent organizational skills with the ability to manage multiple projects and deadlines.
• A collaborative mindset coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
• Advanced knowledge of English (both written and verbal)
• Experience with centralised procedures advantageous
• Experience with regulatory databases and dossier management software advantageous

Additional Information :

When you join Ergomed Group you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. Youll join a passionate and collaborative team of experts in clinical research pharmacovigilance and quality consulting.  

We are diverse in many ways yet our values unite us. Our values are how we work not words on a wall. If they sound like you you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 

• Integrity and trust: we do the right thing especially when it is hard. 

• Drive and passion: we care about the outcome because someone is waiting on it. 

• Agility and responsiveness: we move quickly because patients cannot wait. 

• Belonging: everyone is welcome and every voice counts. 

• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application. 

Remote Work :

Yes

Employment Type :

Full-time