Regulatory Affairs - Global CMC Specialist

Job Description

This is fantastic opportunity for a dynamic and competent CMC specialist, wanting to contribute to a growing business and an expanding team and wanting to enter or establish themselves in the pharmaceutical space. The ideal candidate will work with the teamon projects across different pipeline products and lifecycle stages.Client DetailsA pharmaceutical company delivering drug treatments and services for patients, focusing on rare metabolic and neurological genetic conditions.Description

• 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.)

ProfileRequired skills:

• 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

• 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

Keyskills :
CMCRegulatory AffairsApprovalsregulatory complianceSubmissions