Regulatory Affairs CMC Manager
Currently we are looking for a Regulatory Affairs CMC Manager to join our team!
POSITION OVERVIEW
The Regulatory Affairs CMC Manager will be responsible for the CMC part and the development of submission strategies including coordination, authoring and review of new marketing applications and post-approval regulatory filings. The Regulatory Affairs CMC Manager will be working closely with Product Development, QA, external vendors, and partner companies to ensure alignment of strategy. The area of responsibility will comprise all aspects of maintenance and lifecycle-management of marketed products but also support in product development, to ensure collaborative connectivity with the key stakeholders, and a focused regulatory approach to supporting country and regional business objectives.
The jobholder will represent the company at external regulatory agency meetings as relevant to their project or product portfolio. The role will develop collaborative and respectful relationships with staff at the National Human Medicines Regulatory Agencies, to build and maintain credibility for Global Development, as related to their products/project.
MAIN RESPONSIBILITIES
- Partner with key stakeholders to develop regulatory strategies for health authority submissions or other product related activities.
- Contribute to and implement regulatory strategies to ensure documentation is available for filings (e.g., New product registrations, Variations, Responses to Questions), as appropriate.
- Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies.
- Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data/documents in accordance with project timelines.
- Write high-quality CMC documents, contribute to CMC regulatory strategies, assuring technical congruency and regulatory compliance by meeting agreed submission deadlines.
- Preparing and submitting New Drug Applications (eCTD)
- Preparation, review, submission, approval, and maintenance of CMC sections for regulatory filings (CTA’s, MAA’s, variations, renewals, etc.)
- Review post-approval changes (change controls), assess the regulatory impact on affected registrations and provide CMC support to write/collate relevant variation packages.
- Adaptation and translation of Product Information (SmPC, labelling & PIL) in compliance with the EU and local legislation.
- Train and educate colleagues/business partners with respect to regulatory requirements.
- Assist in overseeing CMC activities performed by colleagues/business partners
- Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.
- Provide regulatory intelligence to our clients by reviewing and evaluating marketing information, regulations, guidelines, procedures etc.
- Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
- Keep up to date with local and EU legislation, guidelines and practices and quality technical trends
EXPERIENCE, SKILLS AND QUALIFICATIONS
Here at Global Development we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- At least 5 years of previous experience working in regulatory CMC and compiling Module 3 documentation in a pharmaceutical environment
- A relevant educational background (preferably as a Chemist, Pharmacist or Biologist)
- The ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives, and assess the impact of change requests against regulatory guidelines
- An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
- Problem-solving ability, flexibility and team player
- Fluency in written and spoken English
- Strong strategic thinking, analytical and problem-solving skills
- Excellent project management skills
- Ability to manage multiple and varied tasks with attention to detail
The Company offers competitive remuneration, continuous learning and development.
The candidates with above qualifications can send their CVs to hr@globaldevelopment.gr
