Senior Regulatory Affairs Officer
4 weeks ago
You will be responsible for:
- Liaising with both internal and external stakeholders to ensure all regulatory requirements are met.
- Co-ordinating and submitting PSURs and preparing responses to questions from Regulatory Authorities.
- Monitoring product safety information, maintaining product labelling and reviewing artworks for use in submissions.
- At least 3 years experience in Regulatory roles within the Pharmaceutical industry.
- Strong knowledge of CTD requirements (modules 1 to 5).
- Experience working on EU MAA/Variation Submissions.
Regulatory Affairs | RA | Regulatory Affairs Officer | GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module4 | Module 5 | eCTD
-
Senior Regulatory Affairs Specialist
7 days ago
England, United Kingdom Mosaic Regulatory Solutions Full timeRole- Senior Regulatory Affairs Specialist Location - Hampshire - Home working Some travel to site every few months for collaborative projects Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing, R&D,...
-
Senior Regulatory Affairs Officer
3 weeks ago
England, United Kingdom Hyper Recruitment Solutions Ltd Full timeWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. ...
-
Senior Regulatory Affairs Specialist
7 days ago
England, United Kingdom Mosaic Regulatory Solutions Full timeRole- Senior Regulatory Affairs Specialist Location - Hampshire - Home working Some travel to site every few months for collaborative projects Scope: Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing, R&D,...
-
Senior Manager/Director of Regulatory Affairs
4 weeks ago
England, United Kingdom Clinical Professionals Limited Full timeRegulatory Manager/ Senior Manager (UK) Job Type: Permanent Regulatory Affairs Manager/ Senior Manager – UK (line management) Berkshire, UK – Hybrid (3 days in the office) An exciting opportunity to join a growing pharmaceutical company and work as the UK lead and be responsible for the UK regulatory affairs team. This is a great opportunity to...
-
Regulatory Affairs Manager
1 month ago
South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full timeWalker Cole International is currently supporting one of their Global Pharmaceutical clients in the South-East of England to hire a Regulatory Affairs Manager on a contract basis, outside IR35 or via umbrella company if needed. The key responsibilities are: - Provide a Regulatory strategy for submissions of new MAs and license maintenance variations - Work...
-
Regulatory Affairs
2 weeks ago
East Kilbride, South Lanarkshire, United Kingdom Real Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products they have operations in 12 major markets, with marketing and distribution agreements in more than 130...
-
Senior Regulatory Affairs Manager/ Consultant
1 month ago
England, United Kingdom Clinical Professionals Limited Full timeSenior Regulatory Affairs Manager/ Consultant Job Type: Contract Senior Regulatory Affairs Manager/ Consultant – 12 Months Contract Berkshire, UK – Hybrid £60-70PH PAYE We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. This product will...
-
Senior VP of Medical
6 hours ago
England, United Kingdom Beacon Therapeutics (USA) Inc Full timeAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for...
-
Senior VP of Medical
17 minutes ago
England, United Kingdom Beacon Therapeutics (USA) Inc Full timeAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for...
-
Senior Regulatory Affairs Associate
4 weeks ago
England, United Kingdom Michael Page (UK) Full timeAbout Our Client Our client is a globally recognised leader within the medical devices space. With a strong presence in over 100 countries, they are renowned for producing cutting-edge research and innovative solutions that have greatly impacted patients lives around the globe. Job Description Oversee and ensure all regulatory affairs are compliant...
-
Head of Regulatory Affairs and Pharmacovigilance
3 weeks ago
England, United Kingdom Hyper Recruitment Solutions Ltd Full timeHead of Regulatory Affairs and Pharmacovigilance We are currently looking for a Head of Regulatory Affairs and Pharmacovigilance to join a leading Pharmaceutical company based in the Kent area. As the Head of Regulatory Affairs and Pharmacovigilance you will be responsible for providing organisation with strategic advice for the launch of new products in...
-
Senior Regulatory Compliance Officer
3 weeks ago
England, United Kingdom Hyper Recruitment Solutions Ltd Full timeWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. ...
-
Regulatory Affair Specialist
1 month ago
South West London, United Kingdom Harrington Recruitment Ltd Full time**The Role** The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based South-West London. The person should be located a commutable distance to the office.. Working together with colleagues in Germany, the Regulatory Affairs Specialist will be required...
-
Head of Regulatory Affairs
2 weeks ago
East Kilbride, South Lanarkshire, United Kingdom Real Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products they have operations in 12 major markets, with marketing and distribution agreements in more than 130...
-
Head of Regulatory Affairs
4 weeks ago
East Kilbride, United Kingdom Real Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products they have operations in 12 major markets, with marketing and distribution agreements in more than 130...
-
Regulatory Affairs
7 hours ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than...
-
Regulatory Affairs
1 month ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than...
-
Senior Regulatory Affairs Associate contract job
4 weeks ago
England, United Kingdom Michael Page (UK) Full timeOur client is a globally recognised leader within the medical devices space. With a strong presence in over 100 countries, they are renowned for producing cutting-edge research and innovative solutions that have greatly impacted patients lives around the globe. Oversee and ensure all regulatory affairs are compliant with global standards. Develop and...
-
Head of Regulatory Affairs
7 hours ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than...
-
Head of Regulatory Affairs
1 month ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than...