Urgently hiring Deputy Manager- Regulatory Affairs department @Hyderabad
Deputy Manager- Regulatory Affairs
Experience : 8 to 9 years of experience in global regulatory affairs department (USA, EU,
Canada, Australia, India, others) of any top pharma companies.
Qualifications : M. Sc. or M. Pham.
Job Description :
- Lead product registrations (formulation and APIs) in global markets (USA, EU,
Canada, Australia, India, others). - Regulatory strategy design, preparation, gap analysis of submission documents and
authoring technical reports for cross functional teams. - Pre-submission advice on CMC, labeling and Bio studies to CFTs (R&D and Plant).
- Timely submission of effective response to the queries from regulatory authority in
coordination with CFT. - Post approval submission management activities for approved products.
- Risk assessment, troubleshoot and resolve the anticipated regulatory issues.
- Active participation in regulatory inspection preparation and represent the
regulatory function. - Advise/guide on end-to-end regulatory activities related to global market
applications. - Mentor juniors, conduct training sessions on the latest regulatory advances and
requirements to the team. - Experience on the renowned software’s to be utilized in regulatory submissions for
eCTD format. - Systematic process development of policies and procedures for Global market
registrations. - Relationship management with cross functional teams and external regulatory
service partners.
Requirements : Must have hands on experience in product registrations of multiple markets “USA,
EU, Canada, Australia, India, others”.
Must have hands on experience in submission of at least more than 10 products
independently and management of more than 5 products life cycle management.
Must be Proficient in written, verbal, Computer skills and business communication in
English.
Deep knowledge on US FDA, EMA, HC, TGA, CDSCO and ICH guidelines and capability
to interpret for implementation.
Should be self motivated and result oriented.
Ability to multitask and prioritize responsibilities
Interested candidates can share their CV’s to contact@defineplacement.com
7978446917
