Regulatory Affairs Specialist (Promotional)

Type: Contract
Location: Oxford 
Start: ASAP
Company: Pharma

This contract role will support clients Promotional Regulatory Affairs Department and serve as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products.  
 

Responsibilities

• Responsible for maintaining a process and collaborating on establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs

• Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings (e.g. brand team, brand planning, etc.).  Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics.  

• Lead the promotional material review process and make decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of applicable EFPIA/International promotional regulations, corporate standards and policies and business objectives.

• Support the training of stakeholders on the client promotional review process as well as use of the electronic approval system (EAS) as needed.  

• Support to  EU/RoW Medical Affairs activities by providing regulatory review of scientific publications and scientific oral and poster presentations as well as other medical programs and tactics.

• Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed.
 

Requirements

• Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred  

• Track record of increasingly responsible experience in the pharmaceutical industry, including direct experience in advertising and promotional material review. Experience of using Veeva PromoMats electronic approval system is desirable.  

• At least two years’ experience in the Advertising & Promotion field, including excellent working knowledge of IFPMA, EFPIA, and ABPI related advertising codes  

• Strong judgment and decision-making skills 

• Outstanding verbal and written communication skills.