Senior Director Regulatory Affairs
Job details
tranScrip is a leading drug development partner who, in the last 2 decades, has supported over 500 clients deliver many development programmes and regulatory submissions. tranScrip has an excellent reputation for providing strategic regulatory support and for delivering regulatory documents and processes. Our team is growing, and we are searching for highly capable Senior Director Regulatory Affairs to join us and support our clients. Duties and responsibilities Applicants will have extensive experience in all or most of the following areas:
- Provide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes.
- Applies senior regulatory affairs experience in other areas for the conduct of client projects.
- Supports BD and Marketing efforts to support company growth including client pitches, input into proposals, social media activity and speaking events.
- Further development of tranScrip’s capabilities in the area of regulatory strategy.
- Client facing, open to assisting in winning new business and can convey the message and the vision of a science driven organisation.
- EU, UK, and US are the geographical regions of principal interest.
- Line management and leadership of a team of Regulatory Affairs managers.
- Application of expertise in the area of product development regulatory strategy over several years.
- Ability to advise clients on a strategic level covering a broad range of product development stages, geography, therapy areas and products.
- Demonstrating leadership and interpersonal skills.
- Experience and willingness to support BD efforts including social media activities and speaking events
- Life science degree or higher.
- Influencer of culture.
- Commercially minded, understands the workings of a small business and the impact their actions have on the business.
- Pragmatist that works with pace and energy, a doer rather than someone who must take everything via committee.
- Motivated by growth but equally by bringing exceptional quality of work to clients and making a difference to patients.
- A desire to work in a fast paced, high growth environment where they will be a key facilitator of growth.
- High level of attention to detail.
- Good level of proficiency in Microsoft Word, Excel and PowerPoint.
- Outstanding written and oral communication skills.
- Fostering constructive and professional working relationships with clients.
- Delivering on projects on time and within budget.
- Keeping up to date with new or changing regulatory requirements in relevant territories.
- Managing multiple projects and priorities.
- Permanent contract of employment,
- Competitive base salary,
- Bonus scheme,
- Pension scheme,
- Private health insurance and travel insurance,
- Retail discounts,
- Strong focus on CPD,
- Career progression in a rapidly expanding organisation.
- The position of Senior Director Regulatory Affairs will be fully remote based in the UK.
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