Interim Head of Regulatory
Proclinical are recruiting for an Interim Head of Regulatory to join a pharmaceutical organisation. This role is on a contract basis and is located in Basingstoke.
- Enable and cultivate external relationships with the pertinent regulatory agencies and industry affiliations.
- You will develop and execute the regulatory plan and method in line with associate business plans and regulatory needs.
- Guarantee proposal and approval of high-quality regulatory applications in planned timelines.
- Serve as a representative with the regulatory affairs functions as suitable in affiliate leadership team, product planning conversations, etc.
- Produce, execute and uphold local quality system aligned with the international quality system and local guidelines.
- Handle and assist with both internal and external audits/assessments/self-inspections in cooperation with regulatory quality staff.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Familiarity in a leadership role with demonstrable experience in retention and development of individuals.
- Educated to a degree level in a scientific, physical or biological science field or relevant work experience.
- Acquaintance in regulatory affairs, preferably within the UK, know-how of the product safety/regulatory setting, etc.
- Communication skills both verbally and in writing.
- Able to resolve issued and make decisions and judgments.
- Interpersonal and presentation abilities.
- A data-driven individual with the ability to work well both in a team as well as independently.
- Expertise on drug development and clinical research business development procedures and requirements.
- Comprehension of quality systems and benefit risk strategies.
- Solid personal networks and focus on shared learning.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.