Senior Specialist, Regulatory & PV Network

About the Role

The successful candidate will be responsible for driving regulatory and PV deliverables, leading projects of medium to high complexity, and ensuring rapid coordination and management of regulatory tasks. Given the nature of the work, the ability to work independently and as part of a team, with strong leadership and problem-solving skills, is essential. The role also involves staying abreast of changing regulatory and legislative requirements, ensuring the maintenance of regulatory intelligence databases, and the timely dissemination of pertinent changes to the team.

What You Will Do

• Develop and implement regulatory strategies based on regulatory requirements and established PV and regulatory plans.
• Act as a Local Contact Person for Pharmacovigilance for the designated country, ensuring compliance with local regulations and guidelines.
• Assume leadership and functional representation for projects, driving the team to meet agreed targets and comply with procedures and trackers.
• Collaborate with senior team members to develop strategy and manage set-up activities, including project management plans and joint operating procedures.
• Provide strategic input to internal and external customers and identify and address potential risks.
• Problem-solve and support the achievement of satisfactory resolution of performance issues or delivery failures.
• Collect, review, track, and maintain necessary documents and records, including CVs, job descriptions, and training records.
• Ensure correct training assignment and compliance by Local Contact Persons and monitor their performance.
• Provide support to proposal development, input to budgets, and department representation at business development meetings.
• Prepare and review invoices and ensure financial management of projects.
• Foster professional relationships with internal and external contacts to ensure smooth service delivery.
• Participate in audits and inspections and provide department representation as required.
• Track key performance indicators and prepare monthly summary reports.

What We Are Looking For

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or an equivalent experience.
• Strong experience within the pharmaceutical or CRO industry or a regulatory body.
• Good knowledge of ICH GCP and/or GVP and national regulations.
• PV training or working experience and other educational or professional backgrounds as required locally.
• Fluency in English, both written and verbal, and proficiency in the official language of the country of residence.
• Proficiency in German, French, or Italian is a plus but not mandatory.
• Good planning and organizational skills, with the ability to work in a fast-paced environment.
• Strong interpersonal skills, including the ability to work collaboratively and build professional relationships.

Nice to Have

• Experience with project management tools and software.
• Knowledge of regulatory intelligence databases and their maintenance.
• Previous experience as a Local Contact Person for Pharmacovigilance or in a similar regulatory role.
• Certification in regulatory affairs or a related field.

Benefits and Perks

• Opportunity to work with a diverse and inclusive company that values human-centric approaches.
• Collaborative and dynamic work environment with opportunities for professional growth and development.
• Competitive compensation package, though details are not disclosed.
• Flexible remote work arrangements, allowing for a better work-life balance.
• Access to professional development opportunities, including training and education support.
• Recognition and reward for outstanding performance and contributions to the company's success.

• Ensure your CV and cover letter are tailored to the role, highlighting relevant experience in regulatory affairs and pharmacovigilance.
• Be prepared to discuss your understanding of regulatory requirements and how you stay updated on changes in the field.
• Practice your problem-solving skills, as the ability to address complex regulatory issues is crucial for this position.
• Emphasize your leadership and interpersonal skills, as building professional relationships is a key aspect of the job.
• Consider creating a portfolio that showcases your experience with regulatory documents, project management, and team leadership.
• During salary negotiations, highlight your unique skills and experience, and be prepared to discuss your expectations based on industry standards.