Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Job Description
Job Description
Job Description:
The role is accountable for undertaking a variety of regulatory activities under supervision across a range of products and licensing routes for the UK market including:
- Developing regulatory strategy and contribute to regulatory filing activities and documentation (including scientific advice and paediatric investigational plans or orphan designation) for new marketing authorisation (MA) applications and product launches. Ensures regulatory strategies are aligned with local business objectives and deliverables.
- Ensures lifecycle maintenance of assigned authorised products through timely submission of variations renewal applications line extensions and notifications.
- Liaising and negotiating with the MHRA.
- Implementation and communication of MA changes across stakeholder groups. Ensuring all compliance activities are correctly managed.
- Generation and maintenance of prescribing information patient information leaflets and packaging components including artwork management and ensuring regulatory compliance with legislation and company approval systems.
- Developing and maintaining a sound knowledge of UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.
- Representation of regulatory affairs at cross functional meetings including new product launches product acquisitions and adhoc product issues.
- Maintaining a positive relationship with internal and external regulatory contacts.
- Utilising and maintaining company compliance systems in relation to product portfolio and meeting compliance expectations.
- Working as a strong member of the UK regulatory team contributing to departmental meetings adhoc projects and issues.
Qualifications:
BSc. Degree or higher (or equivalent qualifications) in pharmacy or a lifescience subject.
Skills/Knowledge:
- Some exposure to a regulatory affairs department would be an advantage but not essential. Experience in the pharmaceutical industry is preferable in regulatory medical or laboratory position.
- Ability to communicate well verbally and in writing is essential.
- Excellent organisational and planning skills.
- Meticulous attention to detail
- Be flexible enough to successfully handle conflicting time pressures and a large volume of work.
- Must be able to work both alone and as part of a team and take responsibility for managing the daytoday regulatory activities for a portfolio of products.
- Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals
- Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry.
- Ability to identify compliance risks and escalate when necessary
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/8/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
