- Lead Regulatory strategy in Europe on assigned projects
- Help to develop the regulatory strategy across multiple therapeutic areas as well as playing a major role in establishing a regulatory presence in the region.
- Ensure the regulatory affairs plans meet the development and commercial goals and fit with the company’s portfolio strategy
This person will understand the scientific, medical and clinical development aspects of the company’s products in relation to the regulatory environment and will advise and direct the company on the development, approval and commercialisation of the products that are developed, in licensed or acquired in the context of that environment.
The responsibilities associated with the role can be outlined as follows:
- Proven the regulatory expertise in participating or coordinating all due diligence opportunities and making recommendations to senior management.
- Help develop and implement regulatory strategies to obtain product approvals with optimal labeling.
- Contribute to building a regulatory presence in Europe and coordinate the regulatory support required to meet the company’s corporate goals in the region.
- Anticipate when and how regulatory issues may impact the business and diligently and quickly advise colleagues and management accordingly of the issue and proposed plan.
- Work on a collaborative basis both within Europe and globally becoming a fully functional member of a multi-disciplinary team, providing expertise on regulatory matters.
- Proven assessment of CROs, consultants and experts where regulatory support is required.
- Work on special projects that require high level regulatory support & leadership for senior management.
The successful candidate must possess the proven leadership skills and the regulatory affairs experience necessary to design and execute the regulatory affairs strategy across multiple programs.
Recognised for his/her outstanding scientific and technical experience and his/her ability to use a wide network, the candidate will bring an immediate credibility in the regulatory affairs field and a recognised entrepreneurial spirit to build a solid regulatory affairs department.
In detail, you are likely to possess skills and experience in line with the following criteria:
- Over 10 years of regulatory leadership and development experience within the pharmaceutical or biopharmaceutical industry.
- Track record and demonstrated ability to lead cross-functional teams or major project across Europe or globally in multiple therapeutic areas.
- Direct involvement in and knowledge of the preparation and filing of EU MAA and be familiar with CTD requirements and ICH guidelines.
- Professional relationships and direct interactions with the EMA and other health authorities and regulatory agencies such as MHRA, Afssaps, BfArM, IPA and others.
- Significant track record of success in obtaining product approvals in the context of EMEA submissions and panel hearings.
- Substantial strategic regulatory mindset and demonstrated ability in representing his/her company to various regulatory bodies in both diplomatic and persuasive ways.
- An ability to gain acceptance and build trust externally as well as internally across various functions and teams.
- Solution oriented mindset with a “can do” attitude.
- Knowledge and understanding of the role and interrelationship between functions, coupled with an ability to work effectively cross-functionally and cross culturally.
- Keep up to date with relevant Regulatory Intelligence of importance to the assignments given within the company.
Strong management and leadership skills along with strategic thinking ability.
A proactive, innovative, high energy and flexible attitude are also essential characteristics.
Strong interpersonal, communications 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 commitment.
Flexibility and ability to adapt to changing conditions.
Attention to detail and good at balancing when high level and detailed focus is required respectfully.
Results-orientated and an ability to see the key issues within the whole picture allowing others to resolve the details if necessary.
Ability to develop and maintain good relationships, gain the confidence of others, challenge views and present and argue a case without antagonising other people.
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 staff or colleagues allowing them to participate in decisions at their own level.
- A graduate degree in a scientific training.
- MD, PhD, or PharmD or other advanced degree preferred but not essential.