ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.

ID-Clinical Candidates Job - Senior Regulatory Affairs Associate

Reference IDSS000103DP
Title Senior Regulatory Affairs Associate

This company creates new standards of care in therapeutic areas with high unmet medical needs and is a global leader in the discovery, development, manufacturing and commercialisation of innovative therapies. It has a direct commercial presence in 25 key markets, a network of distribution partners in more than 70 additional markets and operations in several new markets, including Central/Eastern Europe, Brazil, China and India.

Requirements: Reporting to the Associate Director (or to the Manager) , the Senior Associate will be primarily responsible for:

* Providing regulatory and scientific support for marketed products or in development.

* RA representative on relevant project teams.

* Regulatory contact with relevant Regulatory Authorities.

Key Roles

- Regulatory representative on relevant multifunctional project teams, internally and externally

- Involved in the regulatory strategy development, communication and implementation for assigned projects/programs such as future clinical submissions and variation, marketing authorizations related applications, CMC application and variation, administrative changes,

- Developing the appropriate documentation to support the registration filings

- Assessing the regulatory requirements at the international level

- ROW responsibility, defining regulatory strategy for earliest approval of submissions in close collaboration with regulatory contact in local market

- Planning and coordinating all aspects of regulatory submissions to EMEA and to National Agencies relevant to assigned projects

- Review of promotional materials for the EU countries, provide regulatory input into campaigns, and ensure internal compliance with company procedures

- Communication with EMEA, National Agencies and National Health Authorities for follow-up on submissions/responses filing/meeting organization and any subjects related to ongoing applications or projects

- Developing and maintaining strong links with international marketing and align strategy according to business needs

- Collaborating when appropriate with logistics to assure regulatory compliance of marketed products and implementation of changes at international level

- Supervision, coaching and mentoring of RA associate

- Representing the company in working group with Pharma Industry and/or Authorities

Should have at least 3 years experience in Regulatory Affairs. CMC and biologics experience preferred.

We are also looking for a Senior RA Consultant to work for an initial 3 month contract with the possibility to extend.

Please call for more information.
Salary Excellent package offered
Location Europe, UK, Berkshire

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