Planet Pharma
Senior Associate Regulatory Affairs
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Senior Associate, Regulatory Affairs
Location: Remote, UK
Contract Length: 12 Months
Start Date: ASAP
Working Pattern: Primarily remote with approximately one on-site team meeting per month.
Overview:
An exciting opportunity has arisen for a Senior Associate, Regulatory Affairs to support regulatory strategy and submission activities across a portfolio of pharmaceutical products. The successful candidate will work as part of a cross-functional team, helping ensure regulatory compliance and supporting product lifecycle management activities within a highly regulated environment.
This role is ideal for a regulatory affairs professional with experience in the pharmaceutical or biotechnology industry who is looking to broaden their regulatory expertise and contribute to product development and commercialization activities.
Key Responsibilities
- Support the development and execution of local and regional regulatory strategies.
- Plan, prepare, and manage regulatory submissions in accordance with local regulations and internal standards.
- Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
- Provide regulatory guidance to support product development, approvals, and lifecycle maintenance.
- Develop and maintain local product labeling in line with legislative requirements.
- Act as a key point of contact with health authorities and regulatory agencies.
- Monitor changes in regulatory legislation and communicate potential impacts to internal stakeholders.
- Support regulatory compliance commitments, including post-approval requirements and agency commitments.
- Participate in the preparation and submission of safety-related communications when required.
- Review and approve promotional and non-promotional materials for regulatory compliance.
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Key Activities
- Contribute to regulatory filing plans for marketing authorizations and lifecycle management activities.
- Coordinate local execution of filing plans and submission timelines.
- Ensure high-quality regulatory submissions are delivered on schedule.
- Create, review, and approve labeling documentation and associated artwork.
- Collaborate with cross-functional teams to support clinical study activities and regulatory requirements.
- Monitor the external regulatory landscape and provide input into regulatory decision-making.
- Support compliance activities relating to ongoing regulatory obligations and commitments.
Required Knowledge & Skills
- Strong understanding of regulatory affairs principles within the pharmaceutical industry.
- Working knowledge of relevant regulations, guidelines, policies, and SOPs.
- Understanding of drug development and product lifecycle management.
- Knowledge of national and regional regulations governing medicinal products.
- Ability to interpret and communicate scientific and clinical information effectively.
- Strong organizational skills with the ability to manage multiple priorities.
- Excellent stakeholder management and communication abilities.
Education & Experience
- Master's degree in a scientific discipline; or
- Bachelor's degree in a scientific discipline plus a minimum of 2 years' relevant industry experience.
Preferred Candidate Profile
- Experience working within Regulatory Affairs in the pharmaceutical, biotechnology, or life sciences sector.
- Familiarity with marketing authorization applications and post-approval lifecycle activities.
- Experience collaborating with regulatory agencies and cross-functional teams.
- Strong attention to detail and commitment to regulatory compliance.
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About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.
Planet Pharma | Life Sciences Recruitment Firm | Career Solutions
Planet Pharma is a global, professional staffing and recruitment company specializing in strategic solutions for the pharmaceutical, biotechnology, device, and related industries.
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