At a Glance
- Tasks: Lead regulatory strategy and provide expert consulting on complex projects.
- Company: Join MMS, an award-winning CRO known for its supportive culture and innovative approach.
- Benefits: Enjoy a collaborative work environment with great employee retention and career advancement opportunities.
- Why this job: Shape the future of clinical research while working with a diverse and inclusive team.
- Qualifications: 15+ years in Regulatory Affairs; advanced degrees preferred; strong communication and problem-solving skills.
- Other info: Opportunity to influence regulatory policies and contribute to impactful projects.
The predicted salary is between 43200 - 72000 Β£ per year.
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognised for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career.
Principal Regulatory Strategist Responsibilities
- Provide consulting and advisory services for complex regulatory issues or projects.
- Author and maintain documentation as required to sustain regulatory compliance.
- Provide senior technical review for complex regulatory projects.
- Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
- Participate on project teams and provide expertise on related regulatory matters.
- Clearly and accurately convey information to peers, supervisors, and other stakeholders.
- Participate in the implementation of new/updated operational strategies to comply with new/updated policies and recommendations.
- Identify new/updated policies and recommendations and may provide professional opinions on the impact of regulatory changes to MMS and Clients.
Requirements
- College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience; Masters or PhD preferred.
- Minimum of 15 yearsβ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (EMA).
- Expert knowledge of scientific principles and concepts.
- Reputation as an emerging leader in the field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organisational and communication skills.
- Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.
Principal Regulatory Strategist (CRO/Pharma Industry) - Europe Regulatory Affairs - Regulatory [...] employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Principal Regulatory Strategist (CRO/Pharma Industry) - Europe Regulatory Affairs - Regulatory [...]
β¨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in the CRO and pharmaceutical industries. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory strategy.
β¨Tip Number 2
Stay updated on the latest regulatory changes and guidelines from EMA and other relevant bodies. This knowledge will not only enhance your expertise but also demonstrate your commitment to staying informed, which is crucial for a Principal Regulatory Strategist role.
β¨Tip Number 3
Consider reaching out to current or former employees of MMS via LinkedIn to gain insights into the company culture and expectations for the role. This can provide you with valuable information that can help you tailor your approach during interviews.
β¨Tip Number 4
Prepare to discuss specific examples from your past experiences where you've successfully navigated complex regulatory issues or led projects. Highlighting your problem-solving skills and ability to work collaboratively will resonate well with the hiring team at MMS.
We think you need these skills to ace Principal Regulatory Strategist (CRO/Pharma Industry) - Europe Regulatory Affairs - Regulatory [...]
Some tips for your application π«‘
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs, particularly any roles that involved consulting or advisory services. Emphasise your expertise in regulatory compliance and any specific projects you've worked on that align with the responsibilities of a Principal Regulatory Strategist.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the pharmaceutical industry and your understanding of the complexities involved in regulatory affairs. Mention specific achievements from your 15+ years of experience that demonstrate your leadership and problem-solving skills.
Showcase Your Knowledge: During the application process, be prepared to discuss your knowledge of scientific principles and concepts. Highlight any experience you have with Marketing Applications (EMA) and your familiarity with clinical trial processes, as these are crucial for the role.
Follow Up: After submitting your application, consider sending a polite follow-up email to express your continued interest in the position. This shows initiative and can help keep your application top of mind for the hiring team.
How to prepare for a job interview at MMS Holdings Inc
β¨Showcase Your Expertise
As a Principal Regulatory Strategist, it's crucial to demonstrate your extensive knowledge in regulatory affairs. Be prepared to discuss your past experiences, particularly those involving complex regulatory issues and marketing applications. Highlight specific examples where you've successfully navigated challenges in the CRO or pharma industry.
β¨Communicate Clearly
Good communication skills are essential for this role. During the interview, practice conveying your thoughts clearly and concisely. Use examples to illustrate how you've effectively communicated with peers and stakeholders in previous roles, especially when discussing regulatory matters.
β¨Demonstrate Problem-Solving Skills
Expect questions that assess your problem-solving abilities. Prepare to discuss situations where you've identified regulatory challenges and how you approached finding solutions. This will showcase your analytical thinking and ability to adapt to new policies and recommendations.
β¨Understand the Company Culture
MMS prides itself on its supportive and innovative culture. Research the company values and be ready to explain how your personal values align with theirs. Showing that you understand and appreciate their work environment can set you apart from other candidates.