Expiry Date: 20-07-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
My team and I would like to introduce to you a new exciting opportunity to join an EU medium sized Biotech that is now looking for an Associate Director in Regulatory CMC for biologics to join their team.
POST-COVID: the official company policy is after Covid you can work from home 3 to 4 days a week as standard.
About the Client:
The company’s vision underpins the ambition to transform lives of the people with rare and severe diseases for good and the focus is always on the patients. They are a research-based bio-pharmaceutical, with a good count of marketed products and one of the first to register a mAb in Europe but now are supporting multiple mAbs and recombinants in Phase 1-3, for global development as well as preparing first BLA/MAAs.
They are very open to hiring both development and lifecycle CMC regulatory specialists with biologicals experience
What the role is about:
At this role, you will lead the global submission for all phases of the product life-cycle (Ph. 1-3), MAA, BLA, NDA and Post-Approval for biologics. You will help your team in setting the CMC regulatory strategies and documentation for new CMC submissions and medical device submissions. Your team of managers will rely on you to share your expertise and coach them to help to their development as well as the GRA team and supply & tech teams will work cross-functionally with your team.
As a Subject Matter Expert, you will also participate and/or lead the Health Authorities interactions and response to CMC questions, define the CMC regulatory strategy for all submissions being prepared and lead the resource planning to meet all deadlines.
Your experience and skills:
Our client is looking for individuals with around 7 years in Pharmaceutical or Medical device industry or regulatory institution in a CMC review capacity with a proven track of successful leadership, authoring and contribution in delivering CMC sections of new MAA, CTA and PA submissions for biologics or chemical entities.
Direct experience in communication and negotiation with regulatory agencies focused in CMC and medical devices regulatory affairs and demonstrated competence in managing cross-functional teams operating in a matrix management organizational experience.
Package and Benefits:
The company is located close to Brussels and they are offering a hybrid model where you will be attending 40% of the time to the office and 60% home based. The package includes a very decent basic salary with 15% bonus with personal and company multipliers, 15% Long term incentive, stock options plan that will grow with you every year, a private petrol car and 38 days off a year!
They are also offering the possibility to relocate for EU citizens and they will provide a relocation package that will help you settle thanks to the tax ruling program that will decrease your taxes by around 30%, a temporary apartment and disturbance allowance with a value ranging from 3-5K EUR.
To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to firstname.lastname@example.org. I will support you throughout the interview and on-boarding experience.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.