Are you motivated by the opportunity to manage all regulatory submissions related to drug products?
Are you an experienced regulatory affairs specialist with at least 4 years Chemistry, Manufacturing and Control (CMC) experience?
Are you based in Ohio, US, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a pharmaceutical organisation specialising in producing treatments for life-threatening infections. Operating worldwide, they are committed to saving lives.
Our client is seeking a regulatory affairs specialist to be responsible for regulatory submissions, interactions and strategy related drug products, which are on-market or under development.
Discover more about our Regulatory Affairs (CMC) Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Regulatory Affairs (CMC) Manager, you will be measured against the following objectives:
1) Developing and implementing CMC strategies for marketed and development drug products from a regulatory affairs standpoint.
2) Working effectively on cross-functional teams and being the primary regulatory CMC contact for assigned products and projects.
3) Contributing to process improvements that have a direct impact on the RA CMC function or other departments.
What you will do:
As the Regulatory Affairs (CMC) Manager, your duties and responsibilities will include:
- Ensuring all processes and products are in compliance with all local, state, and federal rules and regulation.
- Preparing amendments, supplements, annual reports for the North American market.
- Working effectively on cross-functional teams and being the primary regulatory CMC contact for assigned products and projects.
- Developing global regulatory strategies for advanced development projects.
- Reviewing for accuracy, completeness and compliance with regulations, approve and collect all supporting documentation for regulatory submissions.
- Contributing to the product development and maintenance of the existing portfolio from a regulatory aspect.
- Evaluating change controls for regulatory impact and record assessment using internal system.
- Contribute to process improvements, which have a direct impact on the RA CMC function or other departments.
- Working cross-functionally within a matrixed organisation.
What you will bring:
These are the skills and experience you will need to succeed as the Regulatory Affairs (CMC) Manager:
- Confident decision-maker and ability to think strategically.
- Excellent verbal and written communication skills and interpersonal skills.
- Must be self-disciplined to plan, schedule and arrange own activities in alignment with project goals and deadlines autonomously.
- Demonstratable attention to detail and problem-solving abilities.
- General understanding of US CMC regulatory guidelines and regulatory submissions.
- 4+ years of pharmaceutical Regulatory CMC experience.
- Bachelor’s degree in a scientific discipline.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- First position of its kind at one of our client’s state of the art facilities
- Business culture awarding organisation
Got what it takes?
To apply for the Regulatory Affairs (CMC) Manager, click the ‘Apply’ button below or contact the Executive Research Associate – Aidan Russell – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.