Senior Regulatory Affairs Associate Cmc
2 weeks ago
Exciting opportunity to join a growing pharmacetuical business, joining a high performing Regulatory CMC team.
**Client Details**
A pharmaceutical company delivering drug treatments and services for patients, focusing on rare metabolic and neurological genetic conditions.
**Description**
Senior Regulatory Affairs Associate CMC
- Primary point of contact for chemistry, manufacturing and control (CMC) regulatory documents.
- Liaise with internal stakeholders as well as Contract Manufacturing Organisations to assemble and review key quality documents to ensure regulatory compliance.
- Preparation of high-quality CMC regulatory documents for small molecule products to support global regulatory submissions.
- Collaborate with Product Leads to develop Target Product Profile and Regulatory Strategy.
- Act as the Information and Regulatory Change Control Owner for CMC activities and oversee delivery for the team.
- Work to agreed deadlines, with ability to respond readily to changing events and priorities.
- Opportunity to grow within the role and take leadership in CMC strategy with a future potential of line management.
- Create and/maintain regulatory systems as required (submission tracking, gap analysis etc.)
**Profile**
Senior Regulatory Affairs Associate CMC
- Degree in Pharmacy, Chemistry or related discipline, or with extensive experience of working within CMC in Regulatory Affairs (3 years min).
- An accomplished working knowledge of the formulation and / or analytical aspects of pharmaceutical R&D (minimum 2 years).
- Excellent written and oral communication.
- Ability to work in a proactive and autonomous manner, as well as being part of a team with the ability to establish strong relationships and liaise effectively with Contract Manufacturing Organisations worldwide
- Good problem solving and critical thinking in complex, multidisciplinary situations (ideally this would include some programming experience (VBA etc).
- Demonstrate a 'can do' attitude to assume responsibilities beyond own space when the circumstances demand.
- Ability to focus, work with attention to detail and retain critical information.
- Effective organizational / project management skills.
- Ability to express a scientific opinion clearly and concisely and to support the defense of regulatory decisions.
- Be proficient in the use of IT packages such as Word, Excel and Document Management systems (specifically Veeva).
**Preferred experience**:
- CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
- Global experience (including EU, US, CA & UK), in the following types of CMC submissions:
- MAAs/NDAs and/or Lifecycle Management for medicines and managing the related responses to questions
- Briefing documents for Scientific Advice Meetings (Pre-IND, Type C Meetings)
**Job Offer**
Senior Regulatory Affairs Associate CMC
- Seek to have a profound impact on patients and their families;
- Work across a range of different disease states;
- Opportunity for professional development and training;
- Help shape the culture and future of an emerging pharmaceutical company with a grand vision;
- Collaborate with a growing team of experienced professionals;
- Learn from a strong leadership team a with a proven history of success.
- Competitive salary based on experience
- Performance based bonus
- Opportunity to join a fast growing and ambitious business
- Company pension scheme
- 100% employer paid membership for Private Health Insurance
- Life and Critical Illness Insurance
- Corporate Gym membership
- Regular team building events and an agile working environment
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