Job Summary
We are seeking a skilled Associate Director to lead our Regulatory Affairs efforts in Europe. The successful candidate will be responsible for implementing and executing global regulatory development, submission, and lifecycle maintenance strategies for assigned products in the region.
This is an excellent opportunity to leverage your expertise in regulatory affairs to drive business success and contribute to the growth of our organization.
About the Role
* The Associate Director will be responsible for staying abreast of the ever-evolving regulatory and therapeutic landscapes, informing regional and global strategic plans on a continuous basis.
* The successful candidate will assist in building a European regulatory infrastructure that is fit for purpose in line with our product pipeline, patient, and caregiver needs, and in full compliance with European regulatory requirements and standards.
Key Responsibilities
1. Proactively initiate, manage, submit, and maintain regulatory activities in support of the development, commercialization, and maintenance of assigned products in compliance with reporting requirements.
2. Plan, coordinate, and manage Pediatric Investigation Plans and Orphan Designations.
3. Responsible for the planning, coordination, authoring, and finalization of major regulatory components of Marketing and Extension Applications, Renewals, and Variations.
4. Plan and coordinate health authority meetings, including the preparation and authoring of major components of briefing documentation in close collaboration with cross-functional teams.
5. Develop regulatory strategy for assigned products in line with the global regulatory strategy, ensuring competitive labeling and approval timelines in Europe (through centralized, decentralized, or national procedures).
6. Lead the European Regulatory Sub team during major submissions.
7. Monitor, evaluate, and interpret applicable regulatory requirements to assure compliance with external and internal standards.
8. Support early access/compassionate use programs in Europe.
9. Execute team, group, or project objectives to ensure they align with Regulatory strategy and corporate goals.
10. Maintain appropriate communication within the Regulatory Affairs function and other cross-functional departments primarily at the project team level.
11. Participate in professional associations, industry, and trade groups to keep current on regulatory developments, applying knowledge to assigned programs.
Requirements
* Bachelor's or Master's degree in a related field.
* 8 years of relevant drug development experience, including regulatory affairs in the EU.
* Ability to think critically, strategically, independently, and solve problems.
* Excellent written and verbal communication skills.
* Strong interpersonal and teamwork skills.
* Strong regulatory/scientific writing skills.
* Ability to travel both domestically and internationally.
Benefits
* Competitive base salary and bonus package.
* Medical, dental, and vision insurance.
* Employer-paid life, disability, business travel, and EAP coverage.
* 401(k) Plan with a fully vested company match 1:1 up to 5%.
* Employee Stock Purchase Plan with a 2-year purchase price lock-in.
* 15+ vacation days.
* 13-15 paid holidays.
* 10 days of paid sick time.
* Paid parental leave benefit.
* Tuition assistance.
Diversity, Equity, and Inclusion
We are committed to building a diverse, equitable, inclusive, and innovative organization. We strive to create an environment where all employees feel valued and supported, regardless of their background or identity.