Director of Regulatory Affairs

ClinicalPro is seeking a Director of Regulatory Affairs for a leading Pharmaceutical company located in Germany.

This individual will oversee the CMC stages in the Regulatory Affairs for Drugs and Combination products.

Must be eligible to work in Germany.

Responsibilities

• Create and deliver regional regulatory leadership.
• To achieve the organisational and business objectives, lead and build the EMEA RA team.
• Proactively cultivates relationships of trust and bargains with notified bodies, competent authorities, and health authorities.
• Submitting and approving products.
• Establish processes and regulations to guarantee legal compliance in the workplace.
• Serve as the principal point of contact with the EU Authorised Representative (AR) and finish all necessary EU AR approvals.
• Coordinate escalations from EMEA regulatory bodies, working with outside counsel, attending regulatory agency meetings, and, if necessary, notifying Notified Bodies.
• Participate in the gap/impact analysis and evaluation of new or developing rules.
• Work with the corporate, regulatory, and quality teams from EMEA to expand the worldwide market.
• Internal focal point and liaison for post-market quality-related requirements, hazards, and business strategy.
• Building relationships with component authorities and economic operators; bringing post-market compliance escalations to the attention of the EMEA Leadership Team;
• Serving as the Quality Assurance Team’s EMEA extension, supporting Customer Advocacy by providing local support for “Additional Information Requests” from competent authorities, and serving as the leadership team’s point of contact for important post-market product escalations and investigations.

Skills and Requirements

• Master’s degree is preferable.
• Bachelor’s degree and 9–12 years of relevant work experience.
• A comparable mix of education and experience.
• 6–8 years of expertise in team leadership.
• Experience interacting directly with notified bodies (NB), competent authorities (CA), and health authorities with a proven track record.
• Extensive understanding of the EU regulatory environment.
• Practical knowledge of EU laws and regulators.
• Excellent understanding of EU and other related foreign regulatory standards, including those for clinical trials, quality systems, submissions, labelling, and promotion.
• Strong leadership abilities and a track record of growing team members.
• Strong abilities in teamwork, negotiation, and communication with the capacity to successfully interact at all organisational levels worldwide.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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