Manager, Regulatory Affairs

Contract: Permanent Full-Time

Closing Date: 15/11/24

**Starting immediately**

We are a specialist provider to the healthcare industry for Regulatory Affairs projects - and we are rapidly growing in the UK. Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.

We are seeking experienced Regulatory CMC professionals to join our UK team, where you’ll engage in a wide range of client projects. Our work varies from short-term regulatory intelligence tasks and standalone strategy consultations to long-term, sustained outsourcing projects as part of larger teams.

A day in the life of a regulatory consultant is dynamic and unpredictable—you won’t have time to get bored. We thrive on embracing the unexpected and staying ready for the next big shift in the regulatory landscape. If you enjoy new challenges and transformative work, we’d love to have you on our team

**The Role**:
**Key Responsibilities**:

- Provide CTA support for various early development projects.
- Work on diverse regulatory CMC projects, including development activities and NDA filings for biologics (e.g., mAbs, E. coli).
- Contribute to global regulatory strategies with a focus on creativity and innovation, ensuring business benefits while maintaining compliance.
- Author and prepare regulatory submissions aligned with client-specific global strategies, meeting or exceeding expected timelines.
- Prepare responses to health authority queries during development and registration.
- Work with RIM systems, such as Veeva Vault RIM.
- Identify and track required documentation for global submissions, coordinating technical document delivery in line with project timelines.
- Flag potential issues with source documents that may impact submission quality or timelines, and communicate effectively with client stakeholders to ensure clarity and comfort.
- Stay up to date with global regulatory guidelines, trends, and emerging topics to provide informed, cutting-edge advice.

**Requirements**:

- 5-10 years of broad regulatory experience, ideally with both small and large molecule products. Our projects are diverse, so we need someone who can adapt to a variety of challenges.
- Expertise in European regulatory affairs, including regulatory strategy, CMC knowledge, dossier compilation, and post-approval maintenance. Experience with emerging markets and global regulations is a plus.
- Strong familiarity with ICH, EMA, and US FDA guidelines and procedures.
- Ability to work effectively with multinational teams and manage multiple projects simultaneously under tight deadlines.
- Excellent planning, organizational, and interpersonal skills.
- Strong written and verbal communication skills, with the ability to negotiate effectively.
- A BSc, MSc, or PhD in a life sciences field.

**Personality Traits**:
Your workload will be fluid and driven by client needs—no two projects are alike.

We’re looking for someone who is an excellent communicator, a selfless team player, and a brilliant multitasker.

Most importantly, we want someone with a great sense of humor

We strive for a positive, fun work environment while delivering exceptional services to our clients.

If you have a “can-do, why-not” attitude, we’d love to hear from you.

**How to Apply**:
G&L is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.