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This role offers an exciting opportunity for a Regulatory Affairs Manager to oversee and deliver regulatory strategies within the Pharmaceutical industry. The successful candidate will be responsible for managing regulatory activities and ensuring compliance with regulatory requirements.
Client Details
Our client is a reputable player in the Pharmaceutical industry. This company is known for its commitment to innovation and quality in the production of pharmaceutical products.
Description
- Overseeing regulatory actions for CAPAs, AERs and change controls.
- Managing a team of regulatory affairs professionals.
- Ensure lifecycle management activities are conducted according to relevant laws, regulations and standards.
- Overseeing submissions and application processes to obtain necessary updates to permits, licences, certificates, authorisations etc.
- Establish and maintain relationships with regulatory authorities.
- Coordinating with internal and external stakeholders and cross-functional managers and understand business needs.
- Keeping updated with changes in regulatory legislation and guidelines and provide advisory to company's management.
- Training and supporting team members in regulatory affairs.
Profile
A successful Regulatory Affairs Manager should have:
- A degree in Life Sciences or a related field.
- Minimum 2 years experience in supervisory or management roles.
- Awareness of legal framework and forthcoming legislation that may affect the business.
- Understanding of global competent authorities and variations in UK & EU.
- Ability to lead and motivate a team.
- Detailed CMC knowledge / eCTD beneficial.
Job Offer
- An attractive salary package of £70,000 - £75,000 per annum
- Generous holiday leave
- A culture that promotes work-life balance and employee well-being
- Opportunity to make a significant impact in the life science industry
- Access to company benefits
We encourage all candidates who believe they possess the necessary skills and experience to apply. This is a great opportunity to join a company that is making a difference in the life science industry.
