Associate Director Global Submissions Management

Associate Director Global Submissions Management

Hertfordshire, UK – Hybrid 2/3 days per week in the office

Competitive salary and package

An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The Associate Director of Global Submissions Management will oversees the efficient operation of managing regulatory submission processes across the EU, UK, Switzerland, and Growth Market regions. This position requires strategic leadership, operational expertise, and a strong understanding of global regulatory requirements, especially in the EU, UK, and Switzerland.

The Associate Director will ensure the timely and compliant submission of regulatory dossiers, including MAAs, variations, renewals, and other filings while supporting cross-functional teams to ensure alignment with corporate goals. The Associate Director is responsible for the Regulatory Submission Management of a lead compound or submission project identified as critical to business success. As the Associate Director, you will maintain a high level of visibility within the organization. One of your key responsibilities will be presenting on various GSM-related topics that broadcast the mission, achievements, current projects, and developments of the GSM organization, as well as emerging developments and trends in the world of eCTD regulatory submissions..

Key Responsibilities:

·       Regulatory expertise relating to submissions requirements and standards for all ICH regions.

·       Strong pharmaceutical business experience managing staff, contracting, billing, and vendor relations.

·       Demonstrated experience in regulatory submissions management or regulatory operations, with focus on the EU/UK regions.

·       In-depth knowledge of EU/UK regulatory requirements, eCTD format, and the global submission process with the ability to manage complex projects, collaborate with cross-functional teams, and deliver results in fast-paced environment.

·       Strong leadership, communication, and problem-solving skills, with a focus on driving operational excellence.

·       Proficiency with regulatory submission software and document management systems (e.g., Veeva Vault, eCTD submission platforms).

·       Excellent organisational and project management skills, with attention to detail and the ability to prioritise multiple tasks.

·       Strategic mindset with the ability to adapt to changing regulatory landscapes and operational demands, such as familiarity with HL7, ICH, WHO, CDISC or other recognised Health Authority related taskforces, working groups, and development teams.

Requirements:

·       Education; Minimum of a Bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree (MS. Ph.D.) preferred.

·       10 years of CORE regulatory operations/publishing/ submission management.

·       Previous line management experience.

·       A strong communicator who is happy with leading presentations and senior discussions.

·       UK, EU, and emerging market experience.

This is an excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. You will be supported by an established team providing excellent career progression opportunities and a chance to work as a senior figure in the RA team. The role comes with some excellent benefits including a bonus, car allowance life assurance, pension scheme, and private healthcare.

This role does not provide sponsorship and you must have the Right to Work in the UK.

For more details about this position please feel free to contact lucy.kirkaldy@cpl.com