Regulatory Submission Manager

The Regulatory Submission Manager will work in a team of experts, responsible for dossier submissions to EU markets. Further he will act as single point of contact for B2B regulatory activities towards the partners.

Organization structure
The Qualified Person will report directly into the EVP Strategic Regulatory Affairs and will have a dotted line into the B2B organization to ensure ongoing alignment with the business.

Responsibilities:

• Primary responsibilities of this role include, but are not limited to, the following:
• Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedures.
• Coordinate the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects.
• Provide support documentation for the new applications in line with the in-force regulations and /or local pharmaceutical laws depending on the submission type and market.
• Ensure that all responses to authorities’ requests are correct, complete and timely submitted.
• Communicate with third parties to expedite submissions and ensure regulatory compliance.
• Ensure that all the additional processes related to national submissions are submitted on time and that their submission/approval process does not delay the application.
• Ensure that accurate and complete information is timely provided to other departments/third parties.
• Coordinate the arrangements for inspections required by the local authorities.

• 3 – 5 years Regulatory Affairs experience.
• Experience on EU submissions and/or other regions.
• Ability to work effectively without direct supervision and to be able to report succinctly and efficiently.
• Fluent written and spoken English.
• Ability to prioritize own workloads to meet deadlines. Sense of urgency.
• Results and detail-oriented approach to work delivery and output.
• Enthusiastic, proactive, self-driven, and willing to take over new responsibilities.
• Leadership potential.
• Team player, but also able to perform alone.
• Strong communication, interpersonal, and organizational skills.
• Problem solving skills.
• Excellent computer skills including MS Office applications.