Associate Director Regulatory Affairs
A spectacular opportunity has arisen for an Associate Director Regulatory Affairs for a Global Biotech remotely. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Leads the regulatory working team for own region and represents as needed at project team level
- Ensures regional regulatory lifecycle management strategy and submission planning are written and executed according to plan - or oversees if delegated to vendor.
- Partners with the regional/LOC RA and market access colleagues to understand market access and reimbursement requirements and to ensure consolidated inputs into regional product development plans.
- For the project(s)/product(s) within area of responsibility, collaborates with Global and Regional colleagues for the authoring of regional regulatory strategies and ensures execution of own critical deliverables as agreed within the global regulatory strategy and planning.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe). Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
- Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews regional regulatory strategies as well as executes day-to-day activities for projects Leads and manages meetings and / or interactions with regulatory authorities and agency meetings negotiates on behalf of project team as necessary.
- Provides regional regulatory input in due diligence for licensing opportunities, development and /or marketed products.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
- Presents to senior management as requested.
Skills and Requirements
- BSc degree or equivalent in science; advanced degree preferred
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
- Experience in managing relationships with CROs and/or contractors also preferred.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.