Associate Director Global Submissions Management - Permanent Position

Job description:

Associate Director Global Submissions Management - Permanent Position(3766)

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.
By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

The Associate Director of Global Submissions Management (GSM) within the GRSO department 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 Eisai's 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. This role will require effective communication and a strong understanding of the GSM organisation's activities.

What are we looking for?

• 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.
• Undergraduate degree in scientific or information technology field required
• Advance Degrees Preferred

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Hybrid working (Depending on role)
• Car/Car Allowance (Depending on role)
• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Retail discounts
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

What you need to do next

If you are interested in this position, please click ‘apply now’ at the top of this advert. Upon submitting your application, you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.
If you have any questions, please contact us on TalentAcquisition@eisai.net

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

Eisai EMEA EDI Commitment Statement

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society. Our commitment is:

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity

Location: North Mymms, GB

Posted Date: 10/27/2024