Regulatory Affairs Manager (13-month FTC) in Wales

Come and Save Lives with Us! SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.

Having the right culture is as important to us as having the right portfolio. We are guided by our four values:

• We make patients our priority
• We act with accountability and integrity
• We work together as one team
• We look for better ways forward

By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.

Broad Overview

To manage all aspects of regulatory affairs and regulatory compliance for the Company’s licensed products. To ensure that the Company is at a high level of regulatory compliance through continual review of published information from relevant Regulatory Authorities. To support Director, Group Regulatory Affairs and provide Regulatory support to Qualified Persons, Operations and Quality Directors and Managers.

Principle Responsibilities

• Manage the preparation, collation and review the relevant information for timely submission to Regulatory Authorities in accordance with local requirements.
• Manage the evaluation of the regulatory impact of proposed manufacturing changes and to ensure continued compliance with regulatory licences.
• Represent the Regulatory function on multi-disciplinary teams for licensed products with regard to proposed post-marketing changes. Ensure that the regulatory strategy is aligned with project and business objectives and that deliverables are on time.
• Manage the preparation and maintenance of submission documents in support of licensed products (e.g. supplements, variations, annual reports, general correspondence, responses to inquiries from regulatory agencies). Involves the collection, review and assembly of scientific, medical, manufacturing, and other supporting documentation into submission documents.
• Manage revisions to artwork and labelling.
• Manage document control activities as applicable to Regulatory Affairs.
• Support Quality Assurance in the generation of the Annual Product Quality Reviews in line with global procedures for licensed pharmaceutical products.
• Represent the Regulatory function at the site Change Control Review Board and CAPA board as required.
• Provide regulatory impact assessment in support of quality events relating to licensed products.
• Provide regulatory support to commercial contract manufacturing facilities; liaise with contract manufacturers and regulatory contractors and partners on an as needed basis.
• Manage and maintain the relevant Site Master Files and site manufacturing licences.
• Adhere to company policies on environmental, health, safety and workplace policies.
• Ensure compliance with all local laws regulating commercial activities and that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

Education and Experience

• A relevant level of experience within the pharmaceutical industry in a quality or regulatory role.
• Demonstrated knowledge of MHRA, EMA, Health Canada and FDA regulations.
• Educated to degree or equivalent level in a life science subject preferred, but not mandatory.

Skills and Attributes

• Excellent verbal, written and interpersonal skills with ability to articulate views clearly.
• Ensure SERB's regulatory interactions with Competent Authorities are of the highest calibre.
• Proven ability to make recommendations to effectively resolve problems or issues, by using judgement that is consistent with standards, practices, policies, regulation or guidance from governmental bodies.
• Performance driven, customer-focused and cost-conscious dynamic operations professional with a strong influential personality who is comfortable working closely within a multi-disciplinary team across setting.
• Excellent verbal and written communication with the ability to communicate effectively in a multicultural multinational, matrix environment.
• Excellent negotiation skills in dealing with third parties and internal stakeholders.
• Demonstrated ability to interpret information and present salient issues to internal management.
• Commercial acumen and first class analytical and problem solving skills focused on identifying areas within the organisation for which maximum benefit can be obtained.
• Skilled in organisation and prioritisation with a strong attention to detail and a commitment to quality.
• Must be self-motivated with the ability to handle multiple tasks simultaneously.
• Demonstrated advanced computer skills – Microsoft Office preferred.
• Demonstrated success working in a team environment.
• Dynamic Regulatory professional and diligent in all matters of compliance.

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.