CMC Project Lead
80-100 per Hour
12 Month Contract
Proven CMC regulatory affairs experience to plan and execute regulatory affairs strategy. Experience with contributing to the preparation of CMC documentation for regulatory submissions. Someone with recognised outstanding scientific and technical experience, who will bring immediate expert contribution in the CMC regulatory affairs field.
The responsibilities associated with the role:
Help develop and implement CMC regulatory strategies proactively making sure they are taken into account to obtain approvals for post-approval changes where CMC will not be on the critical path for product reaching the patient.
Leading or supporting the preparation and/or review of EU CMC documentation for submission to Health Authorities, which may include for CTAs (IMPDs), substantial modifications, scientific advice briefing documents post-approval variations and response to health authority questions for assigned projects/products.
Support interactions with Health Authorities to agree CMC regulatory strategies to facilitate successful approval of assigned products/projects.
Help build a regulatory presence in Europe and provide regulatory support required by the projects to meet corporate goals in the region.
Anticipate when and how regulatory issues may impact the business and diligently and quickly advise project teams and management accordingly.
Work on a collaborative basis both within Europe and globally becoming a fully functional member of multi-disciplinary teams, providing expertise on CMC regulatory matters.
Contribute to CMC process initiatives to support creation of internal global and local standard operating procedures and guidance documents.
Keep up to date with relevant European regulatory intelligence of importance to the assignments given.
Candidate skills and experience
At least 8 years of CMC regulatory affairs project leadership, at a strategic and operational level, supporting CTAs, MAAs and post-approval activities within the pharmaceutical or biopharmaceutical industry.
Previous experience of working in a regulatory affairs team with specific CMC regulatory responsibility; preferably across multiple regions at the global level.
Be familiar with Module 3 CTD requirements, ICH and EU CMC/Quality guidelines.
A track record of supporting preparation and approval of CMC sections of EU dossiers and response to health authority questions for CTAs(IMPDs), and variations for post approval changes; experience of supporting new product MAAs, PIPs and requirements in other regions will be an advantage.
Direct interactions with the EMA and other health authorities and regulatory agencies such as MHRA, Afssaps, BfArM, IPA and others will be an advantage.
A history of contributing to effective and proactive Regulatory Affairs project teams
A substantial strategic regulatory mindset and demonstrated ability in representing his/her company to various regulatory bodies in both diplomatic and persuasive ways will be an advantage.
An ability to gain acceptance and build trust externally as well as internally across various functions and teams; such as with supply chain, manufacturing, CMC technical, QA , CMOs
Knowledge and understanding of the role and interrelationship between functions, coupled with an ability to work effectively cross-functionally.
Strong scientific and technical knowledge along with strategic thinking ability.
A proactive, innovative , high energy and flexible attitude are also essential characteristics.
Strong interpersonal, communication and influencing skills, the ability to work effectively in a team setting and to interact with people of different cultural, seniority and functional backgrounds.
Hands-on approach, with a high level of pro-activity, commitment and energy.
Flexibility and ability to adapt to changing conditions
Strong attention to detail
Results-orientated and an ability to see the key issues within the whole picture
Tenacity to get results through people with a how can we approach.
Team player and collegiate working style, with a strong loyalty to the company.
The highest integrity and ethical standards
Decision-making strengths, also considering influences and suggestions from colleagues
EDUCATION - A graduate degree in a scientific field And PhD, or PharmD or other advanced degree preferred but not essential.
If you think this role is the role for you, please apply within or send your CV to firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Contact: Mark Bathe
- Reference: JO-2111-479260
Website: Cpl Life Sciences
- Posted: 18th November 2021
- Expires: 16th December 2021