Associate Director, Regulatory CMC

Associate Director, Regulatory CMC

Ascendis Pharma

Hellerup, Denmark

Description

We are looking for an experienced Associate Director in Regulatory Affairs CMC (RA CMC) for one of the late stage projects approaching Life Cycle Management (LCM). You will work closely together with two other colleagues in RA CMC. You will as a team be responsible for the transition of the product from a development project to a marketed product in LCM. In addition, you will be overall RA CMC responsible for the ongoing clinical trials in phase III, be involved in marketing authorization submissions in new countries and handle CMC variations as agreed within the RA project team.

As Associate Director in RA CMC you will report to the Director of RA CMC and be part of the RA CMC team, currently consisting of six very experienced RA CMC colleagues.

You will work closely together with experienced colleagues in regulatory, CMC development, product supply and quality assurance in this product transition process from development to LCM ie you will have many stakeholder interactions on a day to day basis.

Your main responsibilities will be to

  • Establish the regulatory strategy and understand the regulatory requirements for submission of marketing applications globally as part of LCM
  • Plan, review, prepare and submit CMC documentation for marketing applications globally and ensure timelines are met
  • Provide regulatory advice and agree response strategies in relation to Q&A processes related to LCM activities
  • Be responsible for the CMC documentation for on-going clinical trial investigations for a specific project and keep the approved IND and CTA updated by submitting amendments and handle Q&A as needed
  • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
  • Work in a team environment with collaborations across locations and departments with e.g. regulatory strategies for submissions, pre-submission meetings, scientific advice preparation, including writing and supporting regulatory communications
  • Liaise and negotiate with global regulatory authorities as needed for CMC aspects pertaining to LCM including resolution of key regulatory CMC issues to expedite IND/CTA/MAA approvals
  • Contribute to internal regulatory policies and procedures to achieve best practices and work processes and if needed writing SOPs
  • Support the company through regulatory intelligence efforts in staying abreast of newly issued regulatory laws, guidance and technical publications.

The successful applicant will have a proven record with LCM experience and submission of MAA’s globally and you have at least seven years of documented professional experience from a regulatory affairs CMC position in the Pharma industry. In order to be successful in this position you should also have experience with handling of INDs, CTAs in late phase development.

You hold a Master’s degree within Natural Science or a related field. You are proficient in English at a professional level, both written and spoken.

You have excellent collaboration and communication skills. You work well independently for the success of your projects and you are skilled in conflict resolution with strong negotiating skills and ability to think creatively and develop creative solutions. You have a proven ability to build trust and respect within the organization and you are highly committed to deliver outstanding results. Finally, you have a hands-on attitude, professional work ethic and you are teamwork oriented. Finally, you meet the overall goals and timelines for the projects you are involved in.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Denmark     Clinical Research     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Regulatory Affairs     Ascendis Pharma    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies