Regulatory Affairs Team Leader/ Manager

Job content

Regulatory Affairs Team Leader/ Manager

£50,000 – 65,000 per annum (depending on experience level)

Are you an experienced and enthusiastic Regulatory Affairs professional looking for a new, exciting challenge in the pharmaceutical industry?

We are proud to be working with a pharmaceutical manufacturing business based near Slough, whose core values are integrity and high professionalism. This is a brand-new position in the company due to growth, as the company has exciting ongoing expansion plans for 2023/2024 including within the Regulatory Affairs and Production teams.

The business is looking for an individual to provide expert regulatory advice and solutions across the organization. In this job, you would be responsible for ownership of full lifecycle projects whilst taking a hands-on approach. The position would also involve supervision and mentoring of up to 7 initial regulatory staff members.

This job opportunity would be ideal for an experienced Regulatory who already has several years’ experience in the pharmaceutical market (ideally the generics market), due to the seniority and influence required in this responsible role.

This is a fully onsite role, with flexible work hours (40 hours per week, you can choose to start your day any time between 8am-10am each day).

Key Responsibilities/ Duties:

· Management and mentorship of regulatory affairs team members

· Ownership and completion of lifecycle projects

· Pre-approval and post-approval activities

· Collate and submit new applications, look after the lifecycle of submissions

· Variations

· Reclassifications

· Transferring licenses

· Marketing Authorizations

Experience/ Qualifications:

· Relevant Life Sciences Degree

· Minimum 5 years+ Regulatory Affairs experience in the pharma industry

· Thorough NeeS/ eCTD expertise

· Experience with generic products is not essential but would be beneficial

· Previous experience with supervision of others (either line management, mentoring or training)

· Independent worker

· Positive and “can do” attitude

Apply today to be considered for this exciting job opportunity!

Keywords:

Regulations, regulatory affairs, MHRA, pharma, pharmaceutical, generics, generic submissions, RA, reg affairs, MA, marketing authorization, lifecycle, pre-approval, post-approval, variations, life cycle management, manager, senior, supervisor, team leader, lead, solid dose, dosage, GMP, manufacturing, production.

Harris Lord is acting as a recruitment agency for this job vacancy.

Job Types: Full-time, Permanent

Salary: £50,000.00-£65,000.00 per year

Benefits:

• Flexitime

Schedule:

• Day shift
• Flexitime
• Monday to Friday

Work Location: In person