At a Glance
- Tasks: Lead regulatory CMC activities for drug development and commercialization.
- Company: Akebia is dedicated to improving lives affected by Chronic Kidney Disease.
- Benefits: Enjoy competitive pay, bonuses, equity options, and comprehensive health benefits.
- Why this job: Make a real impact in healthcare while working with passionate, innovative colleagues.
- Qualifications: Requires a Bachelor's degree and 8+ years in CMC Regulatory Affairs.
- Other info: Join a diverse team committed to bettering the lives of kidney disease patients.
The predicted salary is between 60000 - 84000 £ per year.
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you?
Akebia is searching for a Senior Director, Regulatory Affairs CMC to lead the regulatory CMC activities for our programs across all phases of development and life-cycle management. The individual will have responsibility for managing CMC-related components of product development and commercialization (e.g., drug substance, drug product, packaging/distribution), as well as for representing Regulatory Affairs on CMC and Program teams and with partners. This position reports to the Vice President, Regulatory Affairs.
Essential Functions & Duties
- Work cross functionally to develop and execute global CMC regulatory strategies for investigational and commercial products.
- Manage, mentor and develop Regulatory CMC direct reports as assigned.
- Lead the preparation of high-quality CMC sections for regulatory submissions including for INDs, IMPDs, the Japanese NDA (JNDA), US NDA, MAAs, and briefing packages.
- Write CMC regulatory documents to support regulatory submissions using industry best practices and internal Akebia standards.
- Develop and implement high-quality Regulatory CMC plans to enable continued compliance in multiple regions.
- Design well-informed global CMC regulatory strategies (US, EU, and Japan).
- Represent Regulatory Affairs on CMC and Program teams and with partners.
- Provide regulatory guidance to the CMC department (e.g., stability protocols, specifications, report reviews, C of A's, product labels, and CMC development plans).
- Collaborate with internal CMC staff, consultants, and QA colleagues, as well as external Contract Manufacturing Organizations (CMOs) to document and resolve technical manufacturing issues under compliance with cGMPs.
- Assist in the preparation for regulatory agency meetings on CMC topics.
- Maintain knowledge of global CMC regulatory requirements and advise internal stakeholders on emerging CMC regulatory trends.
- Participate in regulatory intelligence gathering activities and maintain knowledge of global CMC regulatory requirements.
- Coordinate on-time delivery of high-quality regulatory submissions to regulatory agencies.
- Establish relevant processes and procedures to support the Regulatory Affairs function activities.
- Ensure compliance with regulatory requirements.
Skills & Experience
Basic Qualifications:
- Bachelor's degree.
- 8+ years pharmaceutical industry experience in CMC Regulatory Affairs.
- Experience managing and developing direct reports.
Preferred Qualifications:
- Advanced degree in chemistry, biochemistry, or pharmacy.
- Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages).
- Demonstrated evidence of writing of CMC regulatory documents.
- Knowledge of FDA and ICH CMC regulations and guidelines a must, knowledge of EU and/or Japan CMC regulations desirable.
- Knowledge of drug development.
- Excellent written and oral communication skills.
- Excellent interpersonal skills.
- Strong project management skills and drive for excellence.
Compensation:
Targeted Base: $246,330 - $304,290. Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package; all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebians aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebians believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease.
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.
Sr. Director, Regulatory Affairs - CMC employer: Akebia Therapeutics
Contact Detail:
Akebia Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Director, Regulatory Affairs - CMC
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in CMC. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with Akebia's products and their development pipeline. Understanding their specific therapeutic areas and regulatory needs will help you tailor your discussions and demonstrate your genuine interest in the company during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with CMC submissions, particularly any successful interactions with the FDA or other regulatory bodies. Highlighting your achievements in this area can set you apart from other candidates.
✨Tip Number 4
Stay updated on global CMC regulations and guidelines, especially those relevant to the US, EU, and Japan. Being knowledgeable about current regulatory trends will not only boost your confidence but also show your commitment to the role.
We think you need these skills to ace Sr. Director, Regulatory Affairs - CMC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC Regulatory Affairs. Focus on your achievements in managing regulatory submissions and any successful interactions with regulatory agencies like the FDA.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving lives through regulatory affairs. Mention specific experiences that align with Akebia's mission and how your skills can contribute to their goals.
Highlight Leadership Experience: Since the role involves managing and mentoring direct reports, emphasise your leadership experience. Provide examples of how you've successfully led teams or projects in the past.
Showcase Communication Skills: Given the importance of communication in this role, include examples of your written and oral communication skills. Mention any presentations or documents you've prepared for regulatory submissions.
How to prepare for a job interview at Akebia Therapeutics
✨Understand the CMC Landscape
Make sure you have a solid grasp of the current CMC regulatory environment, especially FDA and ICH guidelines. Familiarise yourself with recent trends and changes in regulations that could impact drug development and submissions.
✨Showcase Your Leadership Skills
As a Senior Director, you'll be expected to manage and mentor a team. Prepare examples of how you've successfully led teams in the past, focusing on your ability to develop talent and drive projects to completion.
✨Prepare for Technical Questions
Expect to be asked about specific CMC-related challenges you've faced and how you resolved them. Be ready to discuss your experience with regulatory submissions, including INDs and NDAs, and how you ensured compliance with cGMPs.
✨Demonstrate Cross-Functional Collaboration
Highlight your experience working with various departments, such as QA and manufacturing. Be prepared to discuss how you’ve effectively collaborated with internal teams and external partners to achieve regulatory goals.