Senior Manager Regulatory Affairs at Park Street People
Full Time
Start Date
Immediate
Expiry Date
24 Nov, 26
0.0
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Pharmaceutical & Personal Care Products
Description
About the job
We are supporting a pharmaceutical company committed to delivering innovative therapies that improve patients’ lives in recruiting a Senior Regulatory Manager. Their global teams collaborate to bring cutting-edge solutions from concept to market while maintaining the highest standards of quality and compliance.
The Role:
We are seeking an experienced Senior Regulatory Manager with strong expertise in EMA regulatory affairs to join their dynamic team. This role offers the opportunity to lead regulatory strategy, manage submissions, and act as a key regulatory advisor for our product portfolio across the European region.
Key Responsibilities:
- Develop and execute regulatory strategies for products under development and marketed products in Europe, ensuring alignment with EMA requirements.
- Lead and manage EMA submissions, including MAA, variations, line extensions, and renewals.
- Act as primary liaison with EMA, competent authorities, and other regulatory bodies.
- Provide regulatory guidance to cross-functional teams (R&D, clinical, quality, commercial) throughout the product lifecycle.
- Evaluate and interpret new regulations, guidance, and industry trends to ensure ongoing compliance.
- Contribute to internal audits, inspections, and regulatory intelligence initiatives.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
- Strong regulatory affairs experience with a focus on EMA submissions.
- Proven experience in preparing and submitting MAA, CTD dossiers, variations, and renewals.
- Strong understanding of EU pharmaceutical regulations and guidelines.
- Excellent written and verbal communication skills.
- Demonstrated ability to lead projects and influence cross-functional teams.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
#J-18808-Ljbffr
Senior Manager Regulatory Affairs in London employer: Y-Axis
At Rolls-Royce, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within our multi-disciplinary teams in Bristol. Our commitment to employee growth is evident through comprehensive training programs and opportunities to lead design activities, ensuring that every team member can thrive while contributing to groundbreaking gas turbine technologies. With generous benefits such as annual leave, group income protection, and a focus on inclusivity, we create an environment where individuals are valued and empowered to make a meaningful impact.
